ComfyHealth
BRACOO TB50 Finger Armor wrap 3D Ergo Fixation & Breathable Support / Grade 5 Black Free size
68manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (12), Zhejiang (11). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Jianxing Shoe Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 11 |
| Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Ningbo NEW Nature Bath Articles Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 6 |
| Roshung International Co., Limited | Qingdao | Shandong | Contract manufacturer | 4 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 68. All 68 manufacturers in China registered for Orthosis, Truncal/Orthosis, Limb
Record
| Listed by | Comfy Health Group Co., Ltd., Taiwan |
|---|---|
| FDA product code | MRI |
| Device type | Orthosis, Truncal/Orthosis, Limb |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-12-05 |
| Record revised | 2025-07-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-03-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP42 | In distribution | |
| EP41 | In distribution | |
| EE92 | In distribution | |
| WB50 | In distribution | |
| TP30 | In distribution | |
| ES10 | In distribution | |
| WP40 | In distribution | |
| WS10 | In distribution | |
| EE92 | In distribution | |
| EP42 | In distribution | |
| EP42 | In distribution | |
| TP32 | In distribution | |
| EE92 | In distribution | |
| TE60 | In distribution | |
| TE60 | In distribution | |
| WB51 | In distribution | |
| TB50 | In distribution | |
| WP40 | In distribution | |
| EE92 | In distribution | |
| EE91 | In distribution | |
| WP40 | In distribution | |
| TE60 | In distribution | |
| WP40 | In distribution | |
| EP40 | In distribution | |
| WP40 | In distribution | |
| WP40 | In distribution | |
| WB30 | In distribution | |
| EP42 | In distribution | |
| SE21 | In distribution | |
| EE92 | In distribution | |
| EP42 | In distribution | |
| WP30 | In distribution | |
| EE92 | In distribution | |
| EE92 | In distribution | |
| EP42 | In distribution | |
| WP40 | In distribution | |
| EE92 | In distribution | |
| EP42 | In distribution | |
| WS10 | In distribution | |
| EP42 | In distribution | |
| WB50 | In distribution | |
| EE91 | In distribution | |
| WP40 | In distribution | |
| EP30 | In distribution | |
| ES10 | In distribution | |
| TP33 | In distribution | |
| EE91 | In distribution | |
| WS10 | In distribution | |
| TB50 | In distribution | |
| ES10 | In distribution | |
| WB31 | Withdrawn | |
| EP43 | Withdrawn | |
| WS11 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 71 |
| Ilso™ | PMT Corp. | 9 |
| Itlso™ | PMT Corp. | 9 |
| DeRoyal | Deroyal Industries, Inc. | 9 |
| Comfytopia | Comfytopia, Inc. | 8 |
| Wellbrace | Pantymed S.A. | 5 |
| WoodyKnows | M&M Pure AIR Systems LLC | 3 |
| Vive | Vive Health LLC | 3 |
| TM “Rehabilitimed” L-4M-2 Xxxl Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” L-4M-3 XL Comfort | Reabilitimed TOV | 2 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 2 |
| Lower Limb Orthotics | Boston Brace International, Incorporated | 2 |
Showing 12 of 50. All products under Orthosis, Truncal/Orthosis, Limb
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.