A TENS (MODEL AI-86)— 510(k) K861709

Substantially Equivalent

American Imex

FDA 510(k) clearance K861709 for A TENS (MODEL AI-86), Substantially Equivalent on 1986-05-16. Applicant: American Imex. Device class: 2.

Clearance details

Applicant: American Imex
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1986-05-05
Decision date: 1986-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Imex

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K895295 — ULTIMA XS MICROCURRENT TENS1989-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.