Identity
- Trade Name
- L300 Go System FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- L300 Go System, Left Thigh Plus FDA UDI
- Model / Reference
- L4P-5001 FDA UDI
- Description
- L300 Go System, Left Thigh Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810188050120 FDA UDI
- 510(k) Number
- K190285 FDA UDI
- FDA Product Code
- IPF FDA UDIGZI FDA UDI
- GMDN Term
- Gait-enhancement electrical stimulation system, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5810 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
No
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 by Bioness Medical, 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
- L100 Go System — BIONESS INC. · Class II
- WalkAide Kit — INNOVATIVE NEUROTRONICS INC. · Class II
- CIONIC — Cionic, Inc. · Class II
- RehaStim 2 for Hocoma — HASOMED GmbH · Class II
- WalkAide Unit — INNOVATIVE NEUROTRONICS INC. · Class II
- L360 Thigh System — BIONESS INC. · Class II
- CIONIC — Cionic, Inc. · Class II
Cleared under the same submission
K190285 also covers:
- L300 Go System — BIONESS INC.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, Inc.
- L300 Go System — Bioness Medical, 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 Medical, Inc.
Sources (1)
- FDA UDI 26f8f7db-4376-45d1-90d9-98ba258aa15c 36 fields · synced Jun 9, 2026