VQ Orthocare
Bionicare Hand System International Medium Right
22manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (16), Beijing (1), Tianjin (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Ebulent Optronics (Shenzhen) Ltd | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
| Netop Industrial Company Limited | Dongguan | Guangdong | Manufacturer | 14 |
Showing 12 of 22. All 22 manufacturers in China registered for Stimulator, Electrical, Transcutaneous, For Arthritis
Record
| Listed by | Vision Quest Industries, Inc., United States |
|---|---|
| FDA product code | NYN |
| Device type | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| 510(k) | K030332 |
| Record published | 2017-07-05 |
| Record revised | 2025-03-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2018-03-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58-91012-404 | In distribution | |
| 58-91012-303 | In distribution | |
| 55-92000-201 | In distribution | |
| 58-91012-203 | In distribution | |
| 55-92000-301 | In distribution | |
| 58-91009-303 | In distribution | |
| 58-91009-203 | In distribution | |
| 55-92000-601 | In distribution | |
| 55-92000-401 | In distribution | |
| 58-91012-204 | In distribution | |
| 58-91009-404 | In distribution | |
| 58-91009-204 | In distribution | |
| 58‑95009‑001 | In distribution | |
| 55-95004-401 | In distribution | |
| 55-95003-401 | In distribution | |
| 58-95012-001 | In distribution | |
| 58-91012-403 | In distribution | |
| 55-95003-301 | In distribution | |
| 55-95004-201 | In distribution | |
| 58-91009-304 | In distribution | |
| AV-IF19A | In distribution | |
| 58-91012-304 | In distribution | |
| 55-95004-301 | In distribution | |
| 58-91009-403 | In distribution | |
| 55-90000-001 | In distribution | |
| 55-92000-501 | In distribution | |
| 55-92000-701 | In distribution | |
| 55-95003-201 | In distribution | |
| 55-92000-999 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PlayMakar | Playmakar, Inc. | 4 |
| Accurelief | Drive DeVilbiss Healthcare | 4 |
| Johari Digital Healthcare Limited | Syrma Johari MedTech Limited | 4 |
| iReliev | Excelhealth Inc. | 4 |
| Icy Hot SmartRelief | Chattem, Inc. | 4 |
| Avail Wireless Pad | Omron Healthcare, Inc. | 2 |
| Avivatens Pain Management | Bio-Medical Research, Ltd. | 1 |
| Kneehab XP | Bio-Medical Research, Ltd. | 1 |
| J-stim | Easymed Instruments Co., Ltd. | 1 |
| Omron Total Power + Heat Tens Unit | Omron Healthcare, Inc. | 1 |
| Seven Seas Distribution and Manufacturing,LLC | Syrma Johari MedTech Limited | 1 |
| Omron Pocket Pain Pro | Omron Healthcare, Inc. | 1 |
Showing 12 of 25. All products under Stimulator, Electrical, Transcutaneous, For Arthritis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142236 | 2015-03-23 |
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.