Electrostim I.F.

FDA 510(k) K873566 · Promatek Industries, Ltd.

Substantially Equivalent

510(k) numberK873566

Submission

Device name
Electrostim I.F.
Applicant
Promatek Industries, Ltd.
Quebec, H4p 2c9, CA
Received
September 2, 1987
Decision date
February 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Electrostim I.F. cleared by the FDA?

Electrostim I.F. (K873566) received a 510(k) decision of Substantially Equivalent on February 1, 1988, 152 days after the submission was received.

What is the product code of K873566?

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