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…

Registry build 21.09.26

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 prosthetic socket thus creating suspension through vacuum.

1manufacturer
11catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ISS
Manufacturer City Province Registered as Device types
Shaoxing Annor Textile Company Limited Shaoxing Zhejiang Contract manufacturer 2

Record

Regulatory record for Nord Sleeve
Listed by Nord Ability AB, Sweden
FDA product code ISS
Device type Prosthesis, Thigh Socket, External Component
Device class Class 1
Regulation 21 CFR 890.3420
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-06-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Nord Sleeve
Catalogue number Size Status
NORD SLEEVE 1.2 – NF34 Size 1 In distribution
NORD SLEEVE 1.2 – NF34 Size 2 In distribution
NORD SLEEVE 1.2 – NF34 Size 4 In distribution
NORD SLEEVE 1.1 – NF29 Size 3 In distribution
NORD SLEEVE 1.1 – NF29 Size 5 In distribution
NORD SLEEVE 1.1 – NF29 Size 4 In distribution
NORD SLEEVE 1.2 – NF34 Size 6 In distribution
NORD SLEEVE 1.2 – NF34 Size 3 In distribution
NORD SLEEVE 1.1 – NF29 Size 2 In distribution
NORD SLEEVE 1.1 – NF29 Size 1 In distribution
NORD SLEEVE 1.2 – NF34 Size 5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Extreme Liner Alps South LLC 154
Superior Performance Liner Alps South LLC 150
Easyliner Alps South LLC 149
Private Label Liner Alps South LLC 120
Ultra Seal Liner Alps South LLC 114
Silicone PRO Liner Alps South LLC 92
General Purpose Liner Alps South LLC 77
Smart Seal Liner Alps South LLC 66
Silicone Liner Alps South LLC 52
Easysleeve Alps South LLC 43
Wintersgel Liner Alps South LLC 42
ECO Liner Alps South LLC 36

Showing 12 of 87. All products under Prosthesis, Thigh Socket, External Component

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer