Transcutaneous Electrical Nerve Stimulator
This Transcutaneous Electrical Nerve Stimulator delivers electrical pulses through skin electrode patches for temporary relief of sore or aching muscles. Its intended areas include the…
This Transcutaneous Electrical Nerve Stimulator delivers electrical pulses through skin electrode patches for temporary relief of sore or aching muscles. Its intended areas include the shoulder, back, arm, leg and foot when pain follows exercise strain or normal household and work activities. The intended users are adults.
The portable unit uses AAA batteries and has an LCD showing mode, intensity and battery status. It offers dual-channel output with adjustable stimulation levels from 0 to 16. The range comprises KTR-206, KTR-208 and KTR-209 models with differing output parameters.
Channel Control and Electrodes
KTR-208 and KTR-209 allow independent intensity adjustment for each output channel. The electrode patches form the skin-contacting components and contain EVA foam, carbon film, hydrogel and PET. The specified contact duration is less than 24 hours; the controller supplies the pulse output through the patches.
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 | Shenzhen Kentro Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | NUH |
| Device type | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K183288 |
| Record published | 2019-10-11 |
| Record revised | 2019-10-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KTR-208 | In distribution | |
| KTR-4036 | In distribution | |
| KTR-209 | In distribution | |
| KTR-4032 | In distribution | |
| KTR-4015 | In distribution | |
| KTR-405 | In distribution | |
| KTR-4012 | In distribution | |
| KTR-4026 | In distribution | |
| KTR-4037 | In distribution | |
| KTR-4029 | In distribution | |
| KTR-4027 | In distribution | |
| KTR-4031 | In distribution | |
| KTR-206 | In distribution | |
| KTR-4039 | In distribution | |
| KTR-4021 | In distribution |
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 |
| 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 |
| iSTIM | Everyway Medical Instruments Co., Ltd. | 9 |
Showing 12 of 230. All products under Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242332 | 2024-11-05 |
| K232517 | 2023-12-08 |
| K222870 | 2023-05-10 |
| K220998 | 2022-08-24 |
| K200177 | 2021-03-25 |
| K200237 | 2020-10-19 |
| K191982 | 2020-09-25 |
| K183288 | 2019-07-30 |
| K170205 | 2017-05-11 |
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.