Tyece OTC EMS System— 510(k) K183454

Substantially Equivalent

Tyece , Ltd.

FDA 510(k) clearance K183454 for Tyece OTC EMS System, Substantially Equivalent on 2019-02-26. Applicant: Tyece , Ltd.. Device class: 2.

Clearance details

Applicant: Tyece , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-12-13
Decision date: 2019-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, Hong Kong, HK

Download summary PDF View on FDA.gov ↗

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More clearances from Tyece , Ltd.

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