XBody
The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It…
The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
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 | Xbody Hungary Kft., Hungary |
|---|---|
| FDA product code | NGX |
| Device type | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| 510(k) | K190038 |
| Record published | 2024-04-09 |
| Record revised | 2023-06-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pro USA | In distribution | |
| Newave USA | In distribution | |
| Go USA | 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 |
|---|---|
| K242926 | 2025-05-30 |
| K221200 | 2023-01-31 |
| K190038 | 2019-04-05 |
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.