Identity
- Trade Name
- L300 Go System FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Hydrogel Electrode Set FDA UDI
- Model / Reference
- LG3-5F00 FDA UDI
- Description
- Hydrogel Electrode Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810188050342 FDA UDI
- 510(k) Number
- K190285 FDA UDI
- FDA Product Code
- IPF FDA UDIGZI FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, reusable
L300 Go System by Bioness Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 32e22c11-bd20-49cc-83be-d484cbf622a1 36 fields · synced Jun 9, 2026