Identity
- Trade Name
- BioStim Pre Wired Butterfly Electrodes FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Pack of three ea EBTF400600 containing two 4" x 6" electrodes. TOTAL 6. FDA UDI
- Model / Reference
- EBTF400600MW FDA UDI
- Description
- Pack of three ea EBTF400600 containing two 4" x 6" electrodes. TOTAL 6. FDA UDI
Identifiers
- Catalog Number
- EBTF400600MW FDA UDI
- Primary DI / UDI-DI
- 00850706007175 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
- 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
Category: Transcutaneous electrical stimulation electrode, single-use
BioStim Pre Wired Butterfly Electrodes by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, single-use.
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- Eswallow — COMPASS HEALTH BRANDS CORP. · Class II
- TMR-ELEC-20003221 2" WH Round electrode — Emsi · Class II
- Medical Science Products — SAUVRE INTERNATIONAL, LTD. · Class II
- AdvanTrode — PEPIN MANUFACTURING, INC. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ProPatch — PRO MEDICAL SUPPLIES, INC. · Class II
- SuperStim Electrodes — COMPASS HEALTH BRANDS CORP. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioMedical Life Systems Inc.
Sources (1)
- FDA UDI aeea8b0b-9060-493e-943d-16000ecc734e 35 fields · synced May 30, 2026