Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MHD TENS

K-Number: K190115 · 2019-06-19

ApplicantMinghuangda Electronic Co., Ltd.
Decision Date2019-06-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MHD TENS is a medical device manufactured by Minghuangda Electronic Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under approval number K190115. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MHD TENS?

MHD TENS is a medical device that received FDA 510(k) clearance on 2019-06-19. It is manufactured by Minghuangda Electronic Co., Ltd.. The 510(k) number is K190115.

When was MHD TENS approved by the FDA?

MHD TENS received FDA 510(k) clearance on 2019-06-19, under approval number K190115.

What company makes MHD TENS?

MHD TENS is manufactured by Minghuangda Electronic Co., Ltd..

What is the FDA product code for MHD TENS?

The FDA product code for MHD TENS is NUH.

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

Official Source

View on FDA Database →

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

↑