Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

Decision Date2019-08-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mini TENS Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) 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. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182871.

When did Mini TENS Therapy Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Mini TENS Therapy Device?

The FDA 510(k) record lists Shenzhen Jumper Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shenzhen Jumper Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.