WiTouch Pro
WiTouch Pro is a wearable transcutaneous electrical nerve stimulator for temporary relief of back pain. It applies electrical stimulation through healthy, intact skin to peripheral nerves,…
WiTouch Pro is a wearable transcutaneous electrical nerve stimulator for temporary relief of back pain. It applies electrical stimulation through healthy, intact skin to peripheral nerves, with indications including muscle aches from activity and back pain associated with arthritis.
The unit adheres across the lower back using replaceable conductive hydrogel pads. It is powered by two AAA batteries and offers four preprogrammed 30-minute stimulation modes with adjustable intensity.
Listed Item
WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.
Controls
A smartphone application controls the unit through Bluetooth, while buttons on the device adjust intensity directly. An optional separate wireless remote is also available. The gel pads are intended for use by one person and are replaced as needed.
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 | Hollywog, LLC, United States |
|---|---|
| FDA product code | NUH |
| Device type | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Manufacturer |
| 510(k) | K171599 |
| Record published | 2018-07-10 |
| Record revised | 2019-10-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 50 to 104 °F; Special storage condition: Store the device, remote control and gel pads in original packaging when not in use.; Handling environment temperature 50 to 104 °F; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 500 to 1060 KiloPascal; Storage environment atmospheric pressure 500 to 1060 KiloPascal |
| Sizes | Outer diameter 18 mm; height 90 mm; width 191 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11.1500 | Outer Diameter 18 mm | 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 |
| 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 |
|---|---|
| K171599 | 2017-09-22 |
| K120500 | 2012-08-20 |
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.