Darco® Night Splint
Extra-large Black Pneumatic
15manufacturers in China registered for this device type
4catalogue 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 International, Inc., United States |
|---|---|
| FDA product code | FZF |
| Device type | Splint, Extremity, Inflatable, External |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3900 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
| 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 | Box of 4, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NS2B | In distribution | |
| NS3B | In distribution | |
| NS4B | In distribution | |
| NS1B | 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 |
| Body Armor® PFA Walker Liner | Darco (Europe) GmbH | 3 |
| 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.