Electronic Stimulator
This electronic stimulator combines transcutaneous electrical nerve stimulation with heating for temporary pain relief. Its rechargeable controller uses built in metal electrodes, with…
This electronic stimulator combines transcutaneous electrical nerve stimulation with heating for temporary pain relief. Its rechargeable controller uses built in metal electrodes, with selected configurations also providing gel electrodes connected through an external coupling.
The family includes devices for the waist and the back of the neck. Five stimulation modes provide electrical pulses, while a wireless remote and controls on the device operate its functions. Model differences include size, electrode arrangement, battery capacity and output parameters.
Listed Item
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Heating and Placement
Heating operates through the metal electrodes and accompanies stimulation rather than running independently. The heating temperature does not exceed 43 degrees Celsius. Treatment locations depend on the model and electrode type, with additional gel patches supporting the specified shoulder, back, arm and leg locations.
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 Leqing Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | NUH |
| Device type | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| 510(k) | K223428 |
| Record published | 2023-05-17 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uNeck-9512A | In distribution | |
| uLumb-9532A | In distribution | |
| LQ-9525B | In distribution | |
| uNeck-9517B | In distribution | |
| uNeck-9521A | In distribution | |
| uNeck-9518A | In distribution | |
| uNeck-9529A | In distribution | |
| uLumb-9533A | In distribution | |
| uLumb-9530A | In distribution | |
| LQ-9535A | In distribution | |
| uLumb-9531A | In distribution | |
| uNeck-9515A | In distribution | |
| uNeck-9519A | 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 |
| 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 |
|---|---|
| K223428 | 2023-05-08 |
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.