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)

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

K-Number: K213788 · 2022-05-06

ApplicantDongguan Bohuikang Technology Co.,Ltd
Decision Date2022-05-06
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is a medical device manufactured by Dongguan Bohuikang Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-05-06 under approval number K213788. 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 TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Dongguan Bohuikang Technology Co.,Ltd. The 510(k) number is K213788.

When was TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) approved by the FDA?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) received FDA 510(k) clearance on 2022-05-06, under approval number K213788.

What company makes TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is manufactured by Dongguan Bohuikang Technology Co.,Ltd.

What is the FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

The FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) 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.

↑