JKH Stimulator Plus
K-Number: K182203 · 2019-03-14
ApplicantJkh USA, LLC
Decision Date2019-03-14
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
JKH Stimulator Plus is a medical device manufactured by Jkh USA, LLC. It received FDA 510(k) clearance on 2019-03-14 under approval number K182203. 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 JKH Stimulator Plus?
JKH Stimulator Plus is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Jkh USA, LLC. The 510(k) number is K182203.
When was JKH Stimulator Plus approved by the FDA?
JKH Stimulator Plus received FDA 510(k) clearance on 2019-03-14, under approval number K182203.
What company makes JKH Stimulator Plus?
JKH Stimulator Plus is manufactured by Jkh USA, LLC.
What is the FDA product code for JKH Stimulator Plus?
The FDA product code for JKH Stimulator Plus is NUH.
Other Devices by Jkh USA, LLC
K182671Medi-Direct TENS Pen
K191151JKH Stimulator Plus
K202851Spo2 Sensor
K201645Massage Compression Boots
K201470Disposable Medical Face Mask
K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG
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.