Icy Hot SmartRelief
SmartRelief is an over-the-counter transcutaneous electrical nerve stimulator for pain relief. It delivers electrical pulses through self-adhesive electrodes on the skin. Its indications…
SmartRelief is an over-the-counter transcutaneous electrical nerve stimulator for pain relief. It delivers electrical pulses through self-adhesive electrodes on the skin. Its indications include temporary relief of sore or aching muscles from exercise or routine activity, management of chronic intractable pain and relief of arthritis-associated pain.
A coin-cell-powered control unit snaps directly onto the electrode without lead wires. The electrode combines both conductive surfaces in one piece. Three buttons turn the device on or off and increase or decrease stimulation intensity.
Listed Item
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) – Club Pack size – Back & Hip
Treatment Controls
The device uses a fixed 30-minute treatment timer. Shaped electrodes and distinctively shaped buttons support placement and control by the user, including when the control unit is difficult to see.
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 | Chattem, Inc., United States |
|---|---|
| FDA product code | NUH |
| Device type | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| 510(k) | K131159 |
| Record published | 2016-09-15 |
| Record revised | 2021-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SmartRelief 1.0 – Club Pack | 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 |
|---|---|
| K131159 | 2013-07-25 |
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.