Identity
- Trade Name
- L300 Go System, Right Lower Leg FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- L300 Go system with Lower Right cuff FDA UDI
- Model / Reference
- LG4-5000 FDA UDI
- Description
- L300 Go system with Lower Right cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020177 FDA UDI
- 510(k) Number
- K162407 FDA UDI
- FDA Product Code
- GZI FDA UDIIPF FDA UDI
- GMDN Term
- Gait-enhancement electrical stimulation system, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gait-enhancement electrical stimulation system, external
L300 Go System, Right Lower Leg by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait-enhancement electrical stimulation system, external.
- WalkLink System ((Clinician Kit) — INNOVATIVE NEUROTRONICS INC. · Class II
- L300 Go System — Bioness Medical, Inc. · Class II
- L300 Go System — Bioness Medical, Inc. · Class II
- L300 Go System — Bioness Medical, Inc. · Class II
- WalkAide Kit — INNOVATIVE NEUROTRONICS INC. · Class II
- CIONIC — Cionic, Inc. · Class II
- RehaStim 2 for Hocoma — HASOMED GmbH · Class II
- L300 Go System — Bioness Medical, Inc. · Class II
Cleared under the same submission
K162407 also covers:
- L300 Go Clinician Kit — BIONESS INC.
- L300 Go Clinician Programmer Software — BIONESS INC.
- L300 Go System, Left Lower Leg — BIONESS INC.
- L300 Go System, Left Small Lower Leg — BIONESS INC.
- L300 Go System, Left Thigh Plus — BIONESS INC.
- L300 Go System, Left Thigh Stand-Alone — BIONESS INC.
- L300 Go System, Right Small Lower Leg — BIONESS INC.
- L300 Go System, Right Thigh Plus — BIONESS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioness Inc.
Sources (1)
- FDA UDI 2b5cfe37-5a46-495e-b462-5efc47bdb9b0 36 fields · synced May 30, 2026