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BioStim INF

FDA UDI

Class II (US FDA UDI)

by BioMedical Life Systems Inc.

Identity

Trade Name
BioStim INF FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Model / Reference
INF FDA UDI

Identifiers

Catalog Number
KBSI FDA UDI
Primary DI / UDI-DI
00857771003217 FDA UDI
510(k) Number
K040824 FDA UDI
FDA Product Code
LIH FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 6 Inch FDA UDI
Width — 2 Inch FDA UDI
Length — 7 Inch FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

BioStim INF by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioMedical Life Systems Inc.

Sources (1)

  • FDA UDI 84ed8c87-cec2-42ae-b56f-30a36028a86b 36 fields · synced Jun 8, 2026