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)

Electronic Pulse Stimulator

K-Number: K153520 · 2016-05-05

ApplicantJkh Health Co., Ltd.
Decision Date2016-05-05
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electronic Pulse Stimulator is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2016-05-05 under approval number K153520. 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 Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K153520.

When was Electronic Pulse Stimulator approved by the FDA?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2016-05-05, under approval number K153520.

What company makes Electronic Pulse Stimulator?

Electronic Pulse Stimulator is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

Related Clinical Trials

NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED NCT07548723 taVNS During Multi-site HRV Measurement: Reliability & Agreement Study ENROLLING_BY_INVITATION NCT03945058 Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure TERMINATED

Other Devices by Jkh Health Co., Ltd.

K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 K200561StimPlus Patch, StimPlus Patch, StimPlus Patch K202839Overlapped Compression Therapy K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 K223541Cold/Hot Compression K240986Cold Compression

View all 10 devices →

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.

↑