Inter Tron 4000

FDA 510(k) K880924 · Diversified Chiropractic Systems

Substantially Equivalent

510(k) numberK880924

Submission

Device name
Inter Tron 4000
Applicant
Diversified Chiropractic Systems
Olathe, KS, US
Received
March 4, 1988
Decision date
October 13, 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 Inter Tron 4000 cleared by the FDA?

Inter Tron 4000 (K880924) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 223 days after the submission was received.

What is the product code of K880924?

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