Masterstim I-2

FDA 510(k) K924490 · Health Care Assoc.

Substantially Equivalent

510(k) numberK924490

Submission

Device name
Masterstim I-2
Applicant
Health Care Assoc.
Springfield, MO, US
Received
September 3, 1992
Decision date
February 5, 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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More from Well-Life Healthcare Limited

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Questions and answers

When was Masterstim I-2 cleared by the FDA?

Masterstim I-2 (K924490) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 155 days after the submission was received.

What is the product code of K924490?

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