Identity
- Trade Name
- BioKnit Conductive Shoulder Support Garment - Kit FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Conductive Shoulder Garment with 4- 2x3 Electrodes FDA UDI
- Model / Reference
- LB0971423 FDA UDI
- Description
- Conductive Shoulder Garment with 4- 2x3 Electrodes FDA UDI
Identifiers
- Catalog Number
- LB0971423-PAD230 FDA UDI
- Primary DI / UDI-DI
- 00857771003354 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
BioKnit Conductive Shoulder Support Garment - Kit by BioMedical Life Systems Inc. — 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.
- 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.
- full back conductive vest- XL — 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
- BioMedical Life Systems Inc.
Sources (1)
- FDA UDI 00e82051-5d4f-43a5-8179-b63a0ad1967a 35 fields · synced May 30, 2026