Identity
- Trade Name
- full back conductive vest- large FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- with (8) 2 x 3 electrodes FDA UDI
- Model / Reference
- KV1004823 FDA UDI
- Description
- with (8) 2 x 3 electrodes FDA UDI
Identifiers
- Catalog Number
- KV1004823 FDA UDI
- Primary DI / UDI-DI
- 00857771003637 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
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
Yes
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
Dimensions & Sizes
- Size
- Height — 12 Inch FDA UDIWidth — 2.5 Inch FDA UDILength — 13 Inch FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
full back conductive vest- large 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.
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- MediMax Tech — MEDIMAX TECH INC. · Class II
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- SuperStim Electrodes — COMPASS HEALTH BRANDS CORP. · Class II
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
- BioMedical Life Systems Inc.
Sources (1)
- FDA UDI 89d3ca3c-66a7-444d-a9bd-282885318fd0 37 fields · synced Jun 6, 2026