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)

Mini TENS Therapy Device

K-Number: K182871 · 2019-08-01

ApplicantShenzhen Jumper Medical Equipment Co., Ltd.
Decision Date2019-08-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mini TENS Therapy Device is a medical device manufactured by Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under approval number K182871. 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 Mini TENS Therapy Device?

Mini TENS Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182871.

When was Mini TENS Therapy Device approved by the FDA?

Mini TENS Therapy Device received FDA 510(k) clearance on 2019-08-01, under approval number K182871.

What company makes Mini TENS Therapy Device?

Mini TENS Therapy Device is manufactured by Shenzhen Jumper Medical Equipment Co., Ltd..

What is the FDA product code for Mini TENS Therapy Device?

The FDA product code for Mini TENS Therapy Device is NUH.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07611643 Bruxism Therapy of Facial Pain RECRUITING

Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Other Devices by Shenzhen Jumper Medical Equipment Co., Ltd.

K170965Fingertip Pulse Oximeter K172795Infrared Thermometer K182437Wireless Intelligent Thermometer K182495Electronic Blood Pressure Monitor K231310Electronic Blood Pressure Monitor

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.

↑