SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator— 510(k) K153045

Name: FDA 510(k) clearance K153045
Creator: U.S. Food and Drug Administration
Published: 2016-05-13

Substantially Equivalent

Easy Med Instrument Co., Ltd.

FDA 510(k) clearance K153045 for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator, Substantially Equivalent on 2016-05-13. Applicant: Easy Med Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Easy Med Instrument Co., Ltd.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2015-10-19
Decision date: 2016-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Daliang, Shunde, Foshan, CN

Download summary PDF View on FDA.gov ↗

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K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN2013-03-28

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Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.