Geko
Pack of 5 pouches, each containing 2 geko T-3 devices. Instructions and patient information in each pack
33manufacturers in China registered for this device type
7catalogue numbers in this listing
10510(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 | Firstkind Ltd, United Kingdom |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K134001 |
| Record published | 2020-11-20 |
| Record revised | 2023-06-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Wallet of 7, shipper of 18 |
| Distribution end date | 2018-06-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| K-1 | In distribution | ||
| T-2 | 100 | In distribution | |
| W-3 | In distribution | ||
| T-3 | 10 | In distribution | |
| A-2 | In distribution | ||
| T-2 | 25 | In distribution | |
| T-3 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220327 | 2022-03-04 |
| K212762 | 2021-11-29 |
| K193045 | 2020-01-18 |
| K191113 | 2019-09-18 |
| K181059 | 2018-05-23 |
| K180082 | 2018-02-11 |
| K163125 | 2017-04-10 |
| K160299 | 2016-04-08 |
| K152677 | 2015-10-23 |
| K133638 | 2014-08-21 |
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.