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)

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

K-Number: K153045 · 2016-05-13

Decision Date2016-05-13
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Easy Med Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) 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. The listed applicant is Easy Med Instrument Co., Ltd.. The 510(k) number is K153045.

When did SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator receive FDA 510(k) clearance?

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

Who is the listed applicant for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA 510(k) record lists Easy Med Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: BXN)

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.