L300 Go System, Left Small Lower Leg
The L300 Go lower-leg system uses electrical stimulation to lift the foot at the ankle in adults and children with foot drop related to upper motor neuron injury or disease. This small-cuff…
The L300 Go lower-leg system uses electrical stimulation to lift the foot at the ankle in adults and children with foot drop related to upper motor neuron injury or disease. This small-cuff configuration stimulates the lower leg; the cuff holds surface electrodes against the leg.
An external pulse generator delivers stimulation through the cuff. Its motion-sensor algorithm can detect heel events to time stimulation during walking. The small lower-leg cuff uses one output channel. A control unit provides wireless remote control and displays system status.
Listed Item
L300 Go system with Small Left cuff
Clinical Fitting
A trained clinician uses the programming software to configure stimulation for the patient. An optional gait sensor can detect heel events and wirelessly synchronize stimulation. The pulse generator is rechargeable.
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) | K162407 |
| Record published | 2017-02-14 |
| Record revised | 2019-11-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 55 °C; Special storage condition: Degrees Celsius |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LG4-5V00 | 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 |
| H200 Wireless | 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.