L100 Go System
The L100 Go System electrically stimulates lower leg muscles to provide ankle dorsiflexion in adults with foot drop or weakness related to upper motor neuron disease or injury. It is…
The L100 Go System electrically stimulates lower leg muscles to provide ankle dorsiflexion in adults with foot drop or weakness related to upper motor neuron disease or injury. It is designed to support gait and can also provide muscle training when the user is not walking.
A pulse generator fits into a lower leg cuff with electrodes against the leg. Integrated motion sensors detect gait events, while the generator’s controls provide the user interface. A clinician configures the system through a tablet application.
Listed Item
L100 Go System, Right
Operating Modes
Gait mode is used for walking, and training mode provides stimulation during seated or lying activities. A separate clinician mode supports enhanced training. An optional smartphone application allows wireless control and review of daily activity.
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) | K200262 |
| Record published | 2025-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 55 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LG1-5Y00 | In distribution | |
| LG1-5Y00 | In distribution | |
| LG1-5X00 | In distribution | |
| LG1-5X00 | 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 |
| 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 |
| 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.