RehaStim 2 / RehaMove 2
RehaStim 2 is an eight-channel functional electrical stimulator that activates muscles through surface electrodes. It can operate alone or with a compatible motorized movement exerciser as…
RehaStim 2 is an eight-channel functional electrical stimulator that activates muscles through surface electrodes. It can operate alone or with a compatible motorized movement exerciser as the RehaMove 2 system.
Connected to a leg-cycle ergometer or suitable arm crank, the controller uses movement-angle information to coordinate stimulation. Active mode combines electrical stimulation with motor assistance where needed; passive mode uses motor-driven movement only.
Listed Item
powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system
Electrodes and Control
Two electrode cables connect up to 16 skin electrodes for the eight stimulation channels. The stimulator has battery-powered portable operation or stationary use, and a cable links it to the movement exerciser. A USB interface supports connection to a computer.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2). 2 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 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Netop Industrial Company Limited | Dongguan | Guangdong | Manufacturer | 14 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Guangzhou Longest Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
| Xemis Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Hasomed Gmbh, Germany |
|---|---|
| FDA product code | GZI |
| Device type | Stimulator, Neuromuscular, External Functional |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5810 |
| Establishment | Manufacturer |
| 510(k) | K112844 |
| Record published | 2016-09-13 |
| Record revised | 2023-06-02 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2018-04-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FES00005 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| L300 Go System | Bioness Medical, Inc. | 22 |
| RT300 | Restorative Therapies Inc. | 20 |
| H200 Wireless System | Bioness Medical, Inc. | 20 |
| Chattanooga | DJO, LLC | 17 |
| Cionic | Cionic | 6 |
| L100 Go System | Bioness Medical, Inc. | 4 |
| MyndStep | Myndtec Inc | 4 |
| ReGrasp | Rehabtronics, Inc. | 4 |
| XFT | Shenzhen XFT Medical Limited | 3 |
| RT200 | Restorative Therapies Inc. | 2 |
| RehaStim 2 | Hasomed Gmbh | 2 |
| H200 Wireless | Bioness Medical, Inc. | 2 |
Showing 12 of 53. All products under Stimulator, Neuromuscular, External Functional
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162683 | 2017-02-03 |
| K132416 | 2014-05-28 |
| K112844 | 2011-10-27 |
| K073237 | 2007-12-27 |
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.