PowerDot PD-01MT2 Muscle Stimulator— 510(k) K210269

Name: FDA 510(k) clearance K210269
Creator: U.S. Food and Drug Administration
Published: 2021-02-23

Substantially Equivalent

Smartmissimo Technologies Pte, Ltd.

FDA 510(k) clearance K210269 for PowerDot PD-01MT2 Muscle Stimulator, Substantially Equivalent on 2021-02-23. 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: 2021-02-01
Decision date: 2021-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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More clearances from Smartmissimo Technologies Pte, Ltd.

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K210938 — PowerDot PD-01MT2 Muscle Stimulator2021-07-30
K181759 — PowerDot PD-01MT2018-11-09
K172876 — PowerDot PD-01M2017-12-04
K150078 — PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)2015-09-30

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