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FDA 510(k)

PowerDot PD-01M

K-Number: K172876 · 2017-12-04

ApplicantSmartmissimo Technologies Pte, Ltd.
Decision Date2017-12-04
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PowerDot PD-01M is the device name listed in this FDA 510(k) record. The listed applicant is Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2017-12-04 under 510(k) number K172876. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerDot PD-01M?

PowerDot PD-01M is a medical device that received FDA 510(k) clearance on 2017-12-04. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K172876.

When did PowerDot PD-01M receive FDA 510(k) clearance?

PowerDot PD-01M received FDA 510(k) clearance on 2017-12-04, under 510(k) number K172876.

Who is the listed applicant for PowerDot PD-01M?

The FDA 510(k) record lists Smartmissimo Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDot PD-01M?

The FDA product code for PowerDot PD-01M is NGX.

Other records listing Smartmissimo Technologies Pte, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210938PowerDot PD-01MT2 Muscle StimulatorK210269PowerDot PD-01MT2 Muscle StimulatorK181759PowerDot PD-01MT

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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