Strap Buddy 5/8″w 10/PK
Catalogue number 5647, listed by Alimed, LLC, United States, under Splint, Hand, And Components. 144 manufacturers in China are registered for this product code.
144manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (36), Zhejiang (32), Jiangsu (30). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | 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 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
Showing 12 of 144. All 144 manufacturers in China registered for Splint, Hand, And Components
Record
| Listed by | Alimed, LLC, United States |
|---|---|
| FDA product code | ILH |
| Device type | Splint, Hand, And Components |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2024-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5647 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 1,511 |
| Splint, Hand, And Components | Tetra Medical Supply Corp. | 111 |
| Plastalume | Brownmed | 102 |
| BMI | Blake Manufacturing, Inc. | 87 |
| Panacea | Blake Manufacturing, Inc. | 78 |
| Klarity Medical | Klarity Medical Products, LLC | 65 |
| Vive | Vive Health LLC | 61 |
| McKie Thumb Splint Pediatric | Mckie Splints, LLC | 60 |
| Performance Health | ASP Global, LLC | 59 |
| McKie Thumb Splint Adult | Mckie Splints, LLC | 47 |
| Wrist Lacer | Medical Specialties, Inc. | 38 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 34 |
Showing 12 of 254. All products under Splint, Hand, And Components
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K822651 | 1982-09-17 |
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.