Focus Knee Replacement Band – Large
Replacement Band for Omron Focus TENS unit - Large
57manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (40), Beijing (2), Tianjin (2). 10 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 |
| Dongguan Quanding Medical Supplies Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Shenzhen Jiantuo Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Ebulent Optronics (Shenzhen) Ltd | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Ansion Technology (GuangDong) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Shenzhen Life-King Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
Showing 12 of 57. All 57 manufacturers in China registered for Stimulator, Nerve, Transcutaneous, Over-The-Counter
Record
| Listed by | Omron Healthcare, Inc., United States |
|---|---|
| FDA product code | NUH |
| Device type | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K183215 |
| Record published | 2020-01-15 |
| Record revised | 2024-12-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment atmospheric pressure 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 5, carton of 10 |
| Distribution end date | 2024-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PMKBAND-L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 114 |
| Transcutaneous Electrical Nerve Stimulators | Shenzhen Kentro Medical Electronics Co., Ltd. | 36 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 28 |
| Avcoo | ADP Health Limited | 23 |
| Roovjoy | Shenzhen Roundwhale Technology Co., Ltd. | 22 |
| Auvon | Shenzhen As-Tec Technology Co., Ltd. | 17 |
| Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 15 |
| Sinrel | Shenzhen Sinrel Tech Ltd | 13 |
| Electronic Stimulator | Shenzhen Leqing Medical Instrument Co., Ltd. | 13 |
| kentro | Shenzhen Kentro Medical Electronics Co., Ltd. | 12 |
| Avazzia | Avazzia, Inc. | 11 |
| Beurer | Beurer North America, L.P. | 10 |
Showing 12 of 230. All products under Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183215 | 2019-09-07 |
| K182120 | 2019-01-10 |
| K181992 | 2018-11-09 |
| K172079 | 2017-10-19 |
| K160115 | 2016-06-03 |
| K141978 | 2014-12-03 |
| K110068 | 2011-12-08 |
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.