Interferential Stimulator Model IMF4150/A

FDA 510(k) K925687 · Biomedical Life Systems, Inc.

Substantially Equivalent

510(k) numberK925687

Submission

Device name
Interferential Stimulator Model IMF4150/A
Applicant
Biomedical Life Systems, Inc.
Vista, CA, US
Received
November 12, 1992
Decision date
March 29, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LIH – Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was Interferential Stimulator Model IMF4150/A cleared by the FDA?

Interferential Stimulator Model IMF4150/A (K925687) received a 510(k) decision of Substantially Equivalent on March 29, 1993, 137 days after the submission was received.

What is the product code of K925687?

The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.