Omron Focus Tens Therapy for Knee – Large
Omron TENS unit is wearable and wireless, battery operated and includes the device, case, band and pad.
22manufacturers in China registered for this device type
1catalogue number
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 | Omron Healthcare, Inc., United States |
|---|---|
| FDA product code | NYN |
| Device type | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K183215 |
| Record published | 2020-01-15 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment humidity 30 to 80 % RH; Storage environment temperature 0 to 40 °C; Storage environment temperature 32 to 104 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 80 % RH; Handling environment temperature 0 to 40 °C |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM710-L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VQ Orthocare | Vision Quest Industries, Inc. | 29 |
| 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 |
Showing 12 of 25. All products under Stimulator, Electrical, Transcutaneous, For Arthritis
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.