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Electronic Pulse Stimulator

by Shenzhen Jingkehui Electronic Co.., Ltd. 3 variants

510(k) K150995

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150995 Date6 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUH
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electronic Pulse Stimulator is a neurology device that provides temporary relief of pain associated with sore and aching muscles. It is designed to be used for pain relief in various parts of the body, including the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

The device is supplied as a Class 2 device with product code NUH and has been cleared through the Traditional 510(k) pathway. It is available with FDA 510(k) clearance, indicated by the k number K150995. The device is intended for single use and is not specified as sterile or non-sterile, and its MRI safety is not stated. The device is stored at the manufacturer's address in Shenzhen, China.

Other devices from Shenzhen Jingkehui Electronic Co.., Ltd.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Electronic Pulse Stimulator used for?

    The Electronic Pulse Stimulator is used for temporary relief of pain associated with sore and aching muscles in various parts of the body, including the shoulder, waist, back, arm, and leg.

  • Is the Electronic Pulse Stimulator sterile?

    The device is not specified as sterile or non-sterile, as this information is not provided in the device data.

  • Can the Electronic Pulse Stimulator be reused?

    The Electronic Pulse Stimulator is intended for single use.

  • What is the regulatory status of the Electronic Pulse Stimulator?

    The device has been cleared through the Traditional 510(k) pathway with FDA 510(k) clearance, indicated by the k number K150995.