Bemer Therapy System
BEMER B.BODY and B.SIT are applicators used with the BEMER Therapy System for noninvasive magnetic field stimulation. The stated purposes are a temporary increase in local circulation in…
BEMER B.BODY and B.SIT are applicators used with the BEMER Therapy System for noninvasive magnetic field stimulation. The stated purposes are a temporary increase in local circulation in healthy leg muscles and stimulation of healthy muscles to facilitate muscle performance.
The applicators connect to a compatible B.BOX controller, which sets the stimulation program and intensity. B.BODY provides a larger application surface, while B.SIT provides a smaller local application surface. Both use magnetic field induction without disposable skin electrodes.
Use Configuration
The applicators are reusable and can be used in home or professional settings. The specified muscle and circulation uses concern healthy muscles and do not establish treatment of vascular disease.
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 | Bemer Int. AG, LI |
|---|---|
| FDA product code | NGX |
| Device type | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K210174 |
| Record published | 2021-02-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B.BODY Professional | In distribution | |
| B.SIT | 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 |
|---|---|
| K231368 | 2023-06-09 |
| K210174 | 2021-02-04 |
| K151834 | 2017-02-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-01-13 | Class II | Labeling Change Control | There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker. | 197,724 units | 2023-07-12 |
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.