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FDA 510(k)

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN

K-Number: K121743 · 2013-03-28

ApplicantSunmed, LLC
Decision Date2013-03-28
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed, LLC. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K121743. 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 EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN?

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Sunmed, LLC. The 510(k) number is K121743.

When did EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN receive FDA 510(k) clearance?

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN received FDA 510(k) clearance on 2013-03-28, under 510(k) number K121743.

Who is the listed applicant for EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN?

The FDA 510(k) record lists Sunmed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN?

The FDA product code for EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN is BXN.

Related Clinical Trials

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.

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Other records listing Sunmed, LLC as applicant

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.

K233098MYOTouch Muscle Stimulator

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.K102084STIMPOD 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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