actiTENS Mini
actiTENS Mini is a body-worn electrical stimulator for pain management in adults older than 22 years. Skin electrodes connect through one or two channels, with a mobile app controlling…
actiTENS Mini is a body-worn electrical stimulator for pain management in adults older than 22 years. Skin electrodes connect through one or two channels, with a mobile app controlling program, intensity, channel selection and duration.
Over-the-counter TENS indications include chronic intractable pain, arthritis pain and temporary relief of sore muscles. A flexible generator fastens to the body for use at home or during professional therapeutic application.
Listed Item
The actiTENS mini is a connected medical device for transcutaneous electrical nerve stimulation (TENS) intended to treat pain in adults. It also contains an electrical muscle strengthening (EMS) program. It is intended for people over 22 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on the body using a fastening accessory. It adapts to the shape of the body with its flexible design. The actiTENS mini can be used discreetly during daily activities. The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing: a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration. It is intended to be used by the patient at home and for therapeutic application by medical professionals.
Prescription Programs
Prescription use additionally covers postoperative or post-traumatic acute pain. The EMS program is prescription-only and supports muscle rehabilitation functions such as spasm relaxation, limiting disuse atrophy, muscle reeducation and maintaining range of motion.
Who Else Makes It
Concentrated in Guangdong (23), Jiangsu (2), Beijing (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Zifound Infonet Technology Co., Ltd. | Shenzhen, Guandong | Guangdong | Contract manufacturer | 2 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
Showing 12 of 32. All 32 manufacturers in China registered for Stimulator, Nerve, Transcutaneous, For Pain Relief
Record
| Listed by | Sublimed, France |
|---|---|
| FDA product code | GZJ |
| Device type | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K252767 |
| Record published | 2026-05-27 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| actiTENS Mini KIT | In distribution | |
| actiTENS Mini | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEM-Stim | Gemore Technology Co., Ltd. | 66 |
| Belifu | Hong Qiangxing (Shen Zhen) Electronics Limited | 55 |
| Neocarbon | Hong Qiangxing (Shen Zhen) Electronics Limited | 38 |
| Domas | Hong Qiangxing (Shen Zhen) Electronics Limited | 30 |
| Avazzia | Avazzia, Inc. | 29 |
| NeuroMD | Hong Qiangxing (Shen Zhen) Electronics Limited | 24 |
| Mastogo | Hong Qiangxing (Shen Zhen) Electronics Limited | 18 |
| EmeTerm | WAT Medical Technology Inc. | 17 |
| Stimease | Hong Qiangxing (Shen Zhen) Electronics Limited | 15 |
| Xpoint | Hong Qiangxing (Shen Zhen) Electronics Limited | 15 |
| Globus | Domino SRL | 13 |
| Omega | Hong Qiangxing (Shen Zhen) Electronics Limited | 12 |
Showing 12 of 358. All products under Stimulator, Nerve, Transcutaneous, For Pain Relief
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252767 | 2026-01-16 |
| K202159 | 2020-12-22 |
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.