L360 Thigh System
The L360 Thigh System electrically stimulates leg muscles to assist knee bending or straightening. It is intended for adults with muscle weakness related to upper motor neuron disease or…
The L360 Thigh System electrically stimulates leg muscles to assist knee bending or straightening. It is intended for adults with muscle weakness related to upper motor neuron disease or injury, such as stroke or damage to spinal cord pathways. The stimulation is applied through electrodes in a thigh cuff.
An external pulse generator supplies the stimulation and gives visual, audible and tactile feedback. It can use motion sensing to identify heel events and coordinate stimulation. A trained clinician programs the system during fitting, with optional controls supporting wireless operation.
Listed Item
L360 Thigh System Kit, Right
System Configuration
The system can use one or two thigh cuffs. An optional gait sensor can synchronize stimulation wirelessly, and an optional mobile application allows the patient to control the pulse generator and review 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) | K191587 |
| Record published | 2019-09-30 |
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 |
|---|---|---|
| L4T-6000 | In distribution | |
| L4T-6000 | 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.