Body Armor® PFA Walker Liner
Liner, Gray, XL
15manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (4), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Zhangzhou Recaring Medical Instrument Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 24 |
| Abletech Orthopedics Corporation | New Taipei | Taiwan | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
Showing 12 of 15. All 15 manufacturers in China registered for Splint, Extremity, Inflatable, External
Record
| Listed by | Darco (Europe) GmbH, Germany |
|---|---|
| FDA product code | FZF |
| Device type | Splint, Extremity, Inflatable, External |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3900 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-15 |
| Record revised | 2025-09-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BAPFAL3 | In distribution | |
| BAPFAL4 | In distribution | |
| BAPFAL2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Body Armor® Stirrup Walker | Darco International, Inc. | 20 |
| Darco® AirTraveler™ Walker Liner | Darco International, Inc. | 10 |
| Darco® AirTraveler™ Walker | Darco International, Inc. | 10 |
| First Aid Only | Acme United Corp. | 6 |
| Darco® Night Splint | Darco International, Inc. | 4 |
| Darco® Body Armor® Pro Term Liner | Darco (Europe) GmbH | 2 |
| Tidi | Tidi Products, LLC | 2 |
| Darco® Body Armor® ProTerm | Darco (Europe) GmbH | 1 |
| Splint, Extremity, Inflatable, External | Domico Med-Device, LLC | 1 |
| Darco® Body Armor® Pro Term | Darco (Europe) GmbH | 1 |
| SafeSplint | Aparata Medical | 1 |
| Mueller Aircast Ankle Brace Left White | Mueller Sports Medicine, Inc. | 1 |
Showing 12 of 15. All products under Splint, Extremity, Inflatable, External
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.