Prosthesis, Thigh Socket, External Component

Who Makes This Device Type in China?

The one Chinese manufacturer registered for this device type is based in Zhejiang. 1 is a contract manufacturer.

Shaoxing Annor Textile Company Limited Zhejiang, contract manufacturer

How Is ISS Classified?

Prosthesis, Thigh Socket, External Component is FDA product code ISS, Class 1, 21 CFR 890.3420.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

Prosthesis, Thigh Socket, External Component

Lumo Socket D-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Aqua Liner XS

Catalogue number SA701.1XS, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Aqua Liner L

Catalogue number SA701.4L, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket B-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket C-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket E-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket E-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket F-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Spacer, STD-A

Catalogue number 03131001, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Heavy-Duty4

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Heavy-Duty1

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Office2

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Heavy-Duty3

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket D-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket D-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

ComfortSil.soft -6mm-

ComfortSil.soft -6mm- silicone liner with distal connection, one-piece knit cover, 10 cm outer matrix, antibacterial finish

Prosthesis, Thigh Socket, External Component

Lumo Socket C-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket D-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Spacer, STD-D

Catalogue number 03131004, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

ContexGel.protect

ContexGel.protect, length: 19 cm

Prosthesis, Thigh Socket, External Component

Sleeve Office4

Sleeve to be worn over residual limb/socket

Prosthesis, Thigh Socket, External Component

Sleeve Heavy-Duty2

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket A-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket B-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Tapered Sleeve

Anterior Posterior Tapered Sleeve Size 26

Prosthesis, Thigh Socket, External Component

Anterior Posterior Tapered Liner

Anterior Posterior Tapered Cushion Liner Size 28

Prosthesis, Thigh Socket, External Component

Lumo Socket E-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket C-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket B-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Spacer, STD-B

Catalogue number 03131002, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Aqua Liner M

Catalogue number SA701.3M, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Full Suction Liner

8 catalogue numbers from FSL28-6, listed by Alps South LLC, United States, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Aqua Liner S

Catalogue number SA701.2S, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Spacer, STD-E

Catalogue number 03131005, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Socket C-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Superior Suspension Sleeve

HD Superior Suspension Sleeve - Black

Prosthesis, Thigh Socket, External Component

Lumo Socket F-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Module Connector

Catalogue number 0314100, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Skin Reliever

Skin Reliever-Gel Sheath 3mm

Prosthesis, Thigh Socket, External Component

Lumo Socket B-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Lumo Spacer, STD-C

Catalogue number 03131003, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Velcro Liner

5 catalogue numbers from JWFR44-6, listed by Alps South LLC, United States, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

AK-Control.Sil -2 Mm-

AK-ControlSil -2 mm-, size 26,5, silicone liner with distal connection, outer matrix without silicone strips, antibacterial finish

Prosthesis, Thigh Socket, External Component

Shock Absorbing Liner

44 CM Shock Absorbing Silicone Cushion

Prosthesis, Thigh Socket, External Component

Wintersgel Liner

WintersGel Locking Liner

Prosthesis, Thigh Socket, External Component

Liberty Liner

Liberty Liner II Locking 6mm

Prosthesis, Thigh Socket, External Component

Lumo Socket A-2

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Profit Liner

Profit Gray Locking Liner Size 44 3mm

Prosthesis, Thigh Socket, External Component

Extreme Sleeve

16 catalogue numbers from SFK16-3, listed by Alps South LLC, United States, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Office1

Sleeve to be worn over residual limb/prosthesis socket

Prosthesis, Thigh Socket, External Component

Lumo Socket F-1

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Sleeve Office3

Catalogue number SA900, listed by Romedis GmbH, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Flex Sleeve

Alps Flex Sleeve - Custom

Prosthesis, Thigh Socket, External Component

Lumo Socket A-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Aqua Liner XL

Liner to be used over residual limb

Prosthesis, Thigh Socket, External Component

ContexGel.sleeve

ContexGel.sleeve, sand-coloured, knee sleeve, size XXL, length: 38,5 cm, one-piece knit cover, antibacterial finish

Prosthesis, Thigh Socket, External Component

Guardian Liner

Guardian Liner 32-6 w/gripgel

Prosthesis, Thigh Socket, External Component

VIP

VIP - High Vacuum, Convex

Prosthesis, Thigh Socket, External Component

Lumo Socket F-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Nord Liner

26 catalogue numbers from NORD LINER 2.2 - NF34 Size L, listed by Nord Ability AB, Sweden, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Thermoliner

Thermoliner w/Coolmax 6mm

Prosthesis, Thigh Socket, External Component

Lumo Socket A-4

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

Softsil Liner

Softsil Grey Silicone Cushion Liner Size 44

Prosthesis, Thigh Socket, External Component

Viva Sleeve

Viva Sleeve w/Valve

Prosthesis, Thigh Socket, External Component

Smart Seal Liner

SAFR Casting Liner Kit 3M Size 26, 28, 32, 35

Prosthesis, Thigh Socket, External Component

Neoflex

Prosthetic suspension sleeve with knee pad reinforcement in gray color and size 4.0.

Prosthesis, Thigh Socket, External Component

Neoflex Pediatric/junior

Prosthetic suspension sleeve with knee pad reinforcement for pediatric application in charcoal gray with multicolored stitching and in size 2XL.

Prosthesis, Thigh Socket, External Component

Neoflex Active

Prosthetic suspension sleeve with knee pad reinforcement in color gray/black and size 1.0.

Prosthesis, Thigh Socket, External Component

Coolmax Liner

White Gel w/Coolmax

Prosthesis, Thigh Socket, External Component

Superior Performance Sleeve

HD Superior Performance Sleeve

Prosthesis, Thigh Socket, External Component

Nord Sleeve

Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users limb and…

Prosthesis, Thigh Socket, External Component

Tapered Liner

Anterior Posterior Tapered Locking Liner Size 24

Prosthesis, Thigh Socket, External Component

Padsil

Distal Pad - 1.5 XXLarge

Prosthesis, Thigh Socket, External Component

Silicone PRO Liner

Seamless Beige Private Label Silicone Locking

Prosthesis, Thigh Socket, External Component

PSI Liner

Proximal Seal Interface Liner

Prosthesis, Thigh Socket, External Component

Ultra Seal Liner

Ultra Seal Ultra Low Silicone Cushion Liner Size 26

Prosthesis, Thigh Socket, External Component

Silicone Sleeve

Custom 21cm/9in - 30cm/12in Proximal Circumference

Prosthesis, Thigh Socket, External Component

Reinforced Sleeve

Black Preflex Sleeve Size 20 w/Reinforced Fabric

Prosthesis, Thigh Socket, External Component

Easyliner

Easyliner High Performance Cushion

Prosthesis, Thigh Socket, External Component

EZ Flex Liner

EZF Casting Liner Kit 6mm

Prosthesis, Thigh Socket, External Component

Silicone Liner

26 CM Clear Gen Thick

Prosthesis, Thigh Socket, External Component

Private Label Liner

Seamless Beige Private Label HD Gel Locking

Prosthesis, Thigh Socket, External Component

General Purpose Liner

General Purpose Locking Liner Extra Large w/Strip Reinforcement

Prosthesis, Thigh Socket, External Component

Superior Performance Liner

Superior Performance Locking HD Liner Size 16-6

Prosthesis, Thigh Socket, External Component

Extreme Liner

Extreme Cushion Liner w/High Density Gel

Prosthesis, Thigh Socket, External Component

Easysleeve

High Performance Easysleeve

Prosthesis, Thigh Socket, External Component

Lumo Socket E-3

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Prosthesis, Thigh Socket, External Component. 1 manufacturer in China is registered for this product code.

Prosthesis, Thigh Socket, External Component

ECO Liner

ECO Liner Cushion w/High Density Gel

Prosthesis, Thigh Socket, External Component

Who Makes This Device Type in China?

How Is ISS Classified?

What Does It Take to Sell It in the United States?

Where China Actually Supplies