ManaFlexx
ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat…
ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Who Else Makes It
Concentrated in Guangdong (25), Beijing (3), Jiangsu (2). 6 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 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | 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 |
Showing 12 of 33. All 33 manufacturers in China registered for Stimulator, Muscle, Powered
Record
| Listed by | Manamed LLC, United States |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-10-02 |
| Record revised | 2024-07-11 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2024-04-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MF0001-RX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QB1 Nmes System | Motive Health, Inc. | 69 |
| MyndMove | Myndtec Inc | 44 |
| GEM-Stim | Gemore Technology Co., Ltd. | 38 |
| Chattanooga | DJO, LLC | 27 |
| ReGrasp | Rehabtronics, Inc. | 19 |
| Stimulation System | Edan Instruments, Inc. | 16 |
| e-vive II Nmes System | Motive Health, Inc. | 16 |
| L300 Go System | Bioness Medical, Inc. | 11 |
| Motive Knee System | Motive Health, Inc. | 9 |
| Ness H200® Wireless Hand Rehabilitation System | Bioness Medical, Inc. | 9 |
| BodyMed | Boxout, LLC | 8 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 7 |
Showing 12 of 204. All products under Stimulator, Muscle, Powered
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.