Identity
- Trade Name
- L300 Go System FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- L300 Go System, Right Thigh Stand-Alone FDA UDI
- Model / Reference
- L4T-5000 FDA UDI
- Description
- L300 Go System, Right Thigh Stand-Alone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020207 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 Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait-enhancement electrical stimulation system, external.
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- 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
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- L300 Go System — Bioness Medical, Inc. · Class II
Cleared under the same submission
K190285 also covers:
- 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.
- 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 Inc.
Sources (1)
- FDA UDI e109fe2f-33f6-4301-9da9-f2a8573a6240 36 fields · synced May 31, 2026