Pure Impact Touch Control Module
The Pure Impact Touch Control Module is the computer and touchscreen controller for the Pure Impact electrical muscle stimulation system. It runs the treatment program and provides the…
The Pure Impact Touch Control Module is the computer and touchscreen controller for the Pure Impact electrical muscle stimulation system. It runs the treatment program and provides the interface for identifying the patient and selecting the required treatment.
The controller communicates by Bluetooth Low Energy with separate wireless stimulation modules. Those modules deliver electrical pulses through electrode pads placed on the body. The control module is an all-in-one PC with its own software and graphical interface.
Listed Item
Touch control Module (all in one PC and screen) for Powered Muscle Stimulator (EMS)
System Use
Pure Impact is used by health professionals under a physician’s supervision in aesthetic clinics to train healthy abdominal, arm, thigh and buttock muscles. Its intended use excludes treatment of medical diseases or conditions.
Who Else Makes It
Concentrated in Guangdong (40), Beijing (10), Hebei (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Dongguan Quanding Medical Supplies Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Guangdong Ace-Tec Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| 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 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
Showing 12 of 66. All 66 manufacturers in China registered for Stimulator, Muscle, Powered, For Muscle Conditioning
Record
| Listed by | Sofwave Medical Ltd., Israel |
|---|---|
| FDA product code | NGX |
| Device type | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K251746 |
| Record published | 2025-09-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 70 % RH; Storage environment temperature 5 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG00016 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HealthmateForever | Healthmate, Inc. | 74 |
| No | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 39 |
| GEM-Stim | Gemore Technology Co., Ltd. | 16 |
| HiDow | HI-DOW International Inc. | 16 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 16 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Shenzhen Osto Medical Technology Company Limited | 15 |
| mastogo | Hong Qiangxing (Shen Zhen) Electronics Limited | 15 |
| Compex | DJO, LLC | 14 |
| Auvon | UAN Healthcare Limited | 13 |
| Belifu | Hong Qiangxing (Shen Zhen) Electronics Limited | 11 |
| Osito | Shenzhen Osto Medical Technology Company Limited | 11 |
| Domas | Hong Qiangxing (Shen Zhen) Electronics Limited | 10 |
Showing 12 of 231. All products under Stimulator, Muscle, Powered, For Muscle Conditioning
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251746 | 2025-07-02 |
| K250146 | 2025-04-18 |
| K241685 | 2024-08-07 |
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.