Superior Performance Sleeve

HD Superior Performance Sleeve

Registry build 21.09.26
1manufacturer
32catalogue 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 Superior Performance Sleeve
Listed by Alps South LLC, United States
FDA product code ISS
Device type Prosthesis, Thigh Socket, External Component
Device class Class 1
Regulation 21 CFR 890.3420
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-12-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Superior Performance Sleeve
Catalogue number Size Status
SFP20-6 In distribution
SFP44-3 In distribution
SFP38-6 In distribution
SFPHD26-3 In distribution
SFP16-6 In distribution
SFPHD20-3 In distribution
SFP24-3 In distribution
SFP16-3 In distribution
SFPHD16-3 In distribution
SFP26-6 In distribution
SFPHD26-6 In distribution
SFPHD32-6 In distribution
SFP28-6 In distribution
SFPHD44-3 In distribution
SFPHD20-6 In distribution
SFP38-3 In distribution
SFPHD38-6 In distribution
SFPHD16-6 In distribution
SFPHD32-3 In distribution
SFP24-6 In distribution
SFPHD44-6 In distribution
SFP44-6 In distribution
SFPHD38-3 In distribution
SFPHD28-3 In distribution
SFP32-6 In distribution
SFP26-3 In distribution
SFPHD24-3 In distribution
SFP20-3 In distribution
SFPHD28-6 In distribution
SFP32-3 In distribution
SFPHD24-6 In distribution
SFP28-3 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