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FDA 510(k)

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

K-Number: K153045 · 2016-05-13

ApplicantEasy Med Instrument Co., Ltd.
Decision Date2016-05-13
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a medical device manufactured by Easy Med Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under approval number K153045. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Easy Med Instrument Co., Ltd.. The 510(k) number is K153045.

When was SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator approved by the FDA?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator received FDA 510(k) clearance on 2016-05-13, under approval number K153045.

What company makes SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is manufactured by Easy Med Instrument Co., Ltd..

What is the FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is BXN.

Related Clinical Trials

NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT06121232 Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study ACTIVE_NOT_RECRUITING NCT01581580 Deep Brain Stimulation Surgery for Movement Disorders RECRUITING NCT07539025 Cervical Spinal Cord Associative Plasticity RECRUITING

Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025)

Related Devices (Code: BXN)

K162086MultiStim ECOPAJUNK GmbH Medizintechnologie K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.

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.

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