← Back to catalogue

LE BioSleeve

FDA UDI

Class II (US FDA UDI)

by Axiobionics, LLC

Identity

Trade Name
LE BioSleeve FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
Cutaneous Electrode Garment FDA UDI
Model / Reference
7 FDA UDI
Description
Cutaneous Electrode Garment FDA UDI

Identifiers

Catalog Number
69 FDA UDI
Primary DI / UDI-DI
B3676970 FDA UDI
510(k) Number
K141342 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
Not 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

LE BioSleeve by Axiobionics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141342 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Axiobionics, LLC

Sources (1)

  • FDA UDI 4754547f-13f2-4380-b8e9-f4c80784ff5e 36 fields · synced Jun 8, 2026