Vive
4350 Ankle Air Splint (Black) Small
134manufacturers in China registered for this device type
76catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (34), Jiangsu (27), Zhejiang (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| 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 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
Showing 12 of 134. All 134 manufacturers in China registered for Joint, Ankle, External Brace
Record
| Listed by | Vive Health LLC, United States |
|---|---|
| FDA product code | ITW |
| Device type | Joint, Ankle, External Brace |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-13 |
| Record revised | 2023-06-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Packaging | Case of 40, case of 20, case, case of 75, case of 72, case of 60 |
| Distribution end date | 2023-01-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SUP3078BLKXL | In distribution | |
| SUP1089BGE | In distribution | |
| SUP3161BLKS | In distribution | |
| SUP3161BLKXL | In distribution | |
| SUP3078BLKL | In distribution | |
| SUP3159BLKM | In distribution | |
| SUP3159BLKXS | In distribution | |
| SUP3078BLKM | In distribution | |
| SUP3094BLKS | In distribution | |
| SUP3094BLKM | In distribution | |
| SUP1063L | In distribution | |
| SUP2065GRY | In distribution | |
| LVA3012BLK | In distribution | |
| SUP2001 | In distribution | |
| SUP2044 | In distribution | |
| SUP3070BLKM | In distribution | |
| SUP3122BLKL | In distribution | |
| SUP204BLKS | In distribution | |
| SUP2037 | In distribution | |
| SUP3026BLK9 | In distribution | |
| SUP2065BGE | In distribution | |
| SUP1063M | In distribution | |
| SUP3160BLKM | In distribution | |
| LVA2029 | In distribution | |
| SUP3161BLKXS | In distribution | |
| SUP3158BLKXS | In distribution | |
| SUP3122BLKS | In distribution | |
| SUP3041BGEL | In distribution | |
| SUP204BLK | In distribution | |
| SUP3094BLKXL | In distribution | |
| SUP2065BLK | In distribution | |
| SUP3158BLKL | In distribution | |
| SUP1043 | In distribution | |
| SUP3158BLKS | In distribution | |
| SUP3159BLKL | In distribution | |
| RHB1044 | In distribution | |
| SUP3122BLKXL | In distribution | |
| SUP3160BLKS | In distribution | |
| SUP3041BGES | In distribution | |
| SUP1089GRY | In distribution | |
| SUP1038 | In distribution | |
| SUP1068GRY | In distribution | |
| SUP1063S | In distribution | |
| SUP1043BGE | In distribution | |
| SUP3159BLKS | In distribution | |
| SUP3078BLKS | In distribution | |
| SUP3094BLKXS | In distribution | |
| SUP1043GRY | In distribution | |
| SUP2043 | In distribution | |
| SUP2076BLK | In distribution | |
| SUP3094BLKL | In distribution | |
| SUP3160BLKXL | In distribution | |
| SUP3158BLKXL | In distribution | |
| SUP1057BLKL | In distribution | |
| SUP3122BLKM | In distribution | |
| SUP3160BLKL | In distribution | |
| SUP1089BLK | In distribution | |
| SUP3070BLKS | In distribution | |
| SUP1057BLK | In distribution | |
| LVA2029GRY | In distribution | |
| SUP3161BLKM | In distribution | |
| SUP3041BGEM | In distribution | |
| SUP3041BGEXL | In distribution | |
| SUP3158BLKM | In distribution | |
| SUP3159BLKXL | In distribution | |
| SUP2036 | In distribution | |
| SUP3161BLKL | In distribution | |
| SUP3160BLKXS | In distribution | |
| SUP3070BLKL | In distribution | |
| SUP2017GRY | In distribution | |
| SUP2034 | Withdrawn | |
| SUP2029 | Withdrawn | |
| SUP2032 | Withdrawn | |
| SUP2033 | Withdrawn | |
| SUP2035 | Withdrawn | |
| SUP2028 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 480 |
| Medi | Medi Manufacturing Inc | 209 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 134 |
| CoreTech | Vive Health LLC | 118 |
| Donjoy Performance | DJO, LLC | 60 |
| ManaMed | Manamed LLC | 49 |
| Profit | Pantymed S.A. | 43 |
| Push braces | Nea International B.V. | 39 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 36 |
| TruCompress | Vive Health LLC | 35 |
| BMI | Blake Manufacturing, Inc. | 32 |
| Henry Schein | Henry Schein, Inc. | 30 |
Showing 12 of 414. All products under Joint, Ankle, External Brace
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.