PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)— 510(k) K150078

Name: FDA 510(k) clearance K150078
Creator: U.S. Food and Drug Administration
Published: 2015-09-30

Substantially Equivalent

Smartmissimo Technologies Pte, Ltd.

FDA 510(k) clearance K150078 for PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application), Substantially Equivalent on 2015-09-30. Applicant: Smartmissimo Technologies Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Smartmissimo Technologies Pte, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2015-01-15
Decision date: 2015-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code NGX

view all

K253790 — High Intensity Focused Electromagnetic Stimulation Device (FE60)2026-08-13
K253926 — Diacore2026-04-10
K253636 — Zionic Pro Max (EMS)2026-03-12
K253408 — CoolTone2026-01-16
K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)2025-12-09

More clearances from Smartmissimo Technologies Pte, Ltd.

view all

K210938 — PowerDot PD-01MT2 Muscle Stimulator2021-07-30
K210269 — PowerDot PD-01MT2 Muscle Stimulator2021-02-23
K181759 — PowerDot PD-01MT2018-11-09
K172876 — PowerDot PD-01M2017-12-04

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