Sys Stim 294
Powered muscle stimulator, four channel neuromuscular stimulator, multi-function
33manufacturers in China registered for this device type
1catalogue number
13510(k) clearances naming this product code
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 | Mettler Electronics Corp., United States |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K984114 |
| Record published | 2016-09-15 |
| Record revised | 2019-05-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 167 °F; Special storage condition: Operating Temperture: 50-104 F |
| Sizes | Weight 9.4 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ME 294 | Weight 9.4 lb | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233926 | 2024-03-21 |
| K223802 | 2023-10-06 |
| K113017 | 2012-06-26 |
| K031017 | 2003-05-30 |
| K984142 | 1999-02-09 |
| K984114 | 1999-02-09 |
| K964028 | 1997-02-03 |
| K893878 | 1989-12-19 |
| K893879 | 1989-12-19 |
| K860107 | 1986-03-28 |
| K855249 | 1986-03-28 |
| K853750 | 1985-11-26 |
| K850013 | 1985-04-08 |
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.