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SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

by Easy Med Instrument Co., Ltd.

510(k) K153045

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK153045 Date13 May 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BXN
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia by delivering an electrical stimulus near a peripheral motor nerve. It features 50 and 100Hz tetanus, automatic train-of-four, and double burst stimulation. The device delivers sufficient output to ensure supramaximal stimulation.

The SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is supplied ready to use and is regulated as a Class II device with FDA 510(k) clearance. It is manufactured by Easy Med Instrument Co., Ltd. and has been cleared for use in anesthesiology. The device is not indicated for MRI use.

Other devices from Easy Med Instrument Co., Ltd.

  • Easystim Nms-28

    Class II

  • Easy Med TN-28 C

    Class II

  • SmartTENS

    Class II

Questions

AI-generated answers, 24 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 SunStim Peripheral Nerve Stimulator used for?

    The SunStim Peripheral Nerve Stimulator is a battery-powered device designed to monitor the magnitude of neuromuscular block in general anesthesia by delivering electrical stimuli near peripheral motor nerves to ensure proper muscle relaxation during surgical procedures.

  • What stimulation modes does the SunStim Peripheral Nerve Stimulator offer?

    The device features multiple stimulation modes including 50Hz and 100Hz tetanus, automatic train-of-four stimulation, and double burst stimulation, all designed to provide comprehensive neuromuscular monitoring capabilities during anesthesia.

  • Is the SunStim Peripheral Nerve Stimulator single-use or reusable?

    The SunStim Peripheral Nerve Stimulator is supplied ready to use and is regulated as a Class II device. While the device description doesn't explicitly state whether it's single-use or reusable, it's designed to deliver sufficient output to ensure supramaximal stimulation for accurate monitoring.

  • What regulatory approvals does the SunStim Peripheral Nerve Stimulator have?

    The SunStim Peripheral Nerve Stimulator has FDA 510(k) clearance with the K number K153045, classified as a Class II device. It has been cleared specifically for use in anesthesiology and is not indicated for MRI use.