GYMFORM ABS & CORE— 510(k) K142055

Name: FDA 510(k) clearance K142055
Creator: U.S. Food and Drug Administration
Published: 2015-05-11

Substantially Equivalent

Well Brain International , Ltd.

FDA 510(k) clearance K142055 for GYMFORM ABS & CORE, Substantially Equivalent on 2015-05-11. Applicant: Well Brain International , Ltd.. Device class: 2.

Clearance details

Applicant: Well Brain International , Ltd.
Product code: Product code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2014-07-29
Decision date: 2015-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kwai Chung, N.T., HK

Download summary PDF View on FDA.gov ↗

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