TENS and EMS Stimulator, TENS Stimulator— 510(k) K183074

Name: FDA 510(k) clearance K183074
Creator: U.S. Food and Drug Administration
Published: 2020-01-11

Substantially Equivalent

Astek Technology , Ltd.

FDA 510(k) clearance K183074 for TENS and EMS Stimulator, TENS Stimulator, Substantially Equivalent on 2020-01-11. Applicant: Astek Technology , Ltd.. Device class: 2.

Clearance details

Applicant: Astek Technology , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-11-05
Decision date: 2020-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan City, TW

Download summary PDF View on FDA.gov ↗

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