Gymform Total ABS— 510(k) K202653

Name: FDA 510(k) clearance K202653
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Substantially Equivalent

Well Brain International , Ltd.

FDA 510(k) clearance K202653 for Gymform Total ABS, Substantially Equivalent on 2021-01-15. Applicant: Well Brain International , Ltd.. Device class: 2.

Clearance details

Applicant: Well Brain International , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2020-09-14
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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