Identity
- Trade Name
- StimWear FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Conductive duo-sock, dual polarity, 1/package FDA UDI
- Model / Reference
- PLB054-3020 FDA UDI
- Description
- Conductive duo-sock, dual polarity, 1/package FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1900700 FDA UDI
- 510(k) Number
- K053214 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
StimWear by Tensproducts, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transcutaneous electrical stimulation electrode, single-use.
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Cleared under the same submission
K053214 also covers:
- 2XL full back conductive vest — BioMedical Life Systems Inc.
- 3XL full back conductive vest — BioMedical Life Systems Inc.
- BioKnit Back Brace 7" Conductive Garment - Kit — BioMedical Life Systems Inc.
- BioKnit Conductive Garment — BioMedical Life Systems Inc.
- BioKnit Conductive Shoulder Support Garment - Kit — BioMedical Life Systems Inc.
- Conductive Garment Pads — BioMedical Life Systems Inc.
- Univ Full Back w (8) 2x3 electrodes — BioMedical Life Systems Inc.
- conductive back brace soft 48" waist 9" wide — BioMedical Life Systems Inc.
- conductive back brace, soft 7" — BioMedical Life Systems Inc.
- conductive knee brace (soft) — BioMedical Life Systems Inc.
- full back conductive garment vest- med. — BioMedical Life Systems Inc.
- full back conductive vest, small — BioMedical Life Systems 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
- Tensproducts, LLC
Sources (1)
- FDA UDI 435de29e-56d1-42d2-be26-604fb440db18 34 fields · synced Jun 8, 2026