Back-n-Shape II
6 catalogue numbers from 163036, listed by Medical Specialties, Inc., United States, under Orthosis, Lumbo-Sacral. 39 manufacturers in China are registered for this product code.
39manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Fujian (7), Jiangsu (6). 5 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 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Ningbo Regookids Accessories Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
Showing 12 of 39. All 39 manufacturers in China registered for Orthosis, Lumbo-Sacral
Record
| Listed by | Medical Specialties, Inc., United States |
|---|---|
| FDA product code | IPY |
| Device type | Orthosis, Lumbo-Sacral |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 163036 | In distribution | |
| 163032 | In distribution | |
| 163035 | In distribution | |
| 163037 | In distribution | |
| 163038 | In distribution | |
| 163034 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 359 |
| M-Brace Air | Indaco SRL | 42 |
| Wellbrace | Pantymed S.A. | 29 |
| Activday | Indaco SRL | 21 |
| Sacroiliac Belt | Medical Specialties, Inc. | 9 |
| Back-N-Black | Medical Specialties, Inc. | 7 |
| Back-N-Black Low Profile | Medical Specialties, Inc. | 7 |
| Back-n-Black with Thermo Pocket | Medical Specialties, Inc. | 6 |
| Archimed 627 Spinal Brace | Medical Specialties, Inc. | 6 |
| Archimed 637 Spinal Brace | Medical Specialties, Inc. | 6 |
| Archimed 631 Spinal Brace | Medical Specialties, Inc. | 6 |
| Orthosis Lumbar Sacral W/Standard Front Alimed | Alimed, LLC | 5 |
Showing 12 of 89. All products under Orthosis, Lumbo-Sacral
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.