Identity
- Trade Name
- BioStim Pre Wired Oval Electrodes FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 3 pk of 4- 2" x 4" oval pigtail pre wired electrodes FDA UDI
- Model / Reference
- EEOV200400MW FDA UDI
- Description
- 3 pk of 4- 2" x 4" oval pigtail pre wired electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850706007168 FDA UDI
- 510(k) Number
- K160138 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
BioStim Pre Wired Oval Electrodes by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K160138 also covers:
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
- BioMedical Life Systems Inc.
Sources (1)
- FDA UDI e83dca48-5016-430a-b3af-6db4cc608994 36 fields · synced May 30, 2026