H200 Wireless
Clinician Programmer Software for H200 Wireless System
8manufacturers in China registered for this device type
2catalogue numbers in this listing
9510(k) clearances naming this product code
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 | Bioness Medical, Inc., United States |
|---|---|
| FDA product code | GZI |
| Device type | Stimulator, Neuromuscular, External Functional |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K111767 |
| Record published | 2018-02-08 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Degrees Celsius; Storage environment temperature -25 to 70 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H2W-SW01 | In distribution | |
| H2W-SW01 | In distribution |
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 |
| L360 Thigh System | Bioness Medical, Inc. | 2 |
Showing 12 of 53. All products under Stimulator, Neuromuscular, External Functional
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200262 | 2020-03-04 |
| K191587 | 2019-09-12 |
| K190285 | 2019-03-14 |
| K173682 | 2018-03-09 |
| K162407 | 2017-01-27 |
| K123636 | 2013-05-01 |
| K122784 | 2012-12-27 |
| K120853 | 2012-04-20 |
| K103343 | 2011-04-29 |
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.