PowerDot PD-01MT2 Muscle Stimulator— 510(k) K210938

Name: FDA 510(k) clearance K210938
Creator: U.S. Food and Drug Administration
Published: 2021-07-30

Substantially Equivalent

Smartmissimo Technologies Pte, Ltd.

FDA 510(k) clearance K210938 for PowerDot PD-01MT2 Muscle Stimulator, Substantially Equivalent on 2021-07-30. Applicant: Smartmissimo Technologies Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Smartmissimo Technologies Pte, Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-03-29
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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K210269 — PowerDot PD-01MT2 Muscle Stimulator2021-02-23
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Data sourced from openFDA. This site is unofficial and independent of the FDA.