Identity
- Trade Name
- BLUE HAND FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 2"x2" sq., Fabric Top Electrodes, 1 pouch(2 pairs per pouch) FDA UDI
- Model / Reference
- 22SQ FA FDA UDI
- Description
- 2"x2" sq., Fabric Top Electrodes, 1 pouch(2 pairs per pouch) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817625020357 FDA UDI
- 510(k) Number
- K042301 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Blue Hand by Bioprotech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042301 also covers:
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- BLUE HAND — BIOPROTECH INC.
- 2" x 2" Rectangle Electrodes — BioMedical Life Systems Inc.
- Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, 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
- Bioprotech Inc.
Sources (1)
- FDA UDI a76d65ed-991c-4169-b3f5-1c6293cb6721 35 fields · synced May 31, 2026