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FDA 510(k)

EMS100 Tri-Wave Combination Stimulator

K-Number: K171387 · 2017-05-31

ApplicantElite Medical Supply of New York, LLC
Decision Date2017-05-31
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS100 Tri-Wave Combination Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Elite Medical Supply of New York, LLC. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K171387. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS100 Tri-Wave Combination Stimulator?

EMS100 Tri-Wave Combination Stimulator is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Elite Medical Supply of New York, LLC. The 510(k) number is K171387.

When did EMS100 Tri-Wave Combination Stimulator receive FDA 510(k) clearance?

EMS100 Tri-Wave Combination Stimulator received FDA 510(k) clearance on 2017-05-31, under 510(k) number K171387.

Who is the listed applicant for EMS100 Tri-Wave Combination Stimulator?

The FDA 510(k) record lists Elite Medical Supply of New York, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS100 Tri-Wave Combination Stimulator?

The FDA product code for EMS100 Tri-Wave Combination Stimulator is IPF.

Related Devices (Code: IPF)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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