EMS100 Tri-Wave Combination Stimulator
K-Number: K171387 · 2017-05-31
Decision Date2017-05-31
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
EMS100 Tri-Wave Combination Stimulator is a medical device manufactured by Elite Medical Supply of New York, LLC. It received FDA 510(k) clearance on 2017-05-31 under approval 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. It is manufactured by Elite Medical Supply of New York, LLC. The 510(k) number is K171387.
When was EMS100 Tri-Wave Combination Stimulator approved by the FDA?
EMS100 Tri-Wave Combination Stimulator received FDA 510(k) clearance on 2017-05-31, under approval number K171387.
What company makes EMS100 Tri-Wave Combination Stimulator?
EMS100 Tri-Wave Combination Stimulator is manufactured by Elite Medical Supply of New York, LLC.
What is the FDA product code for EMS100 Tri-Wave Combination Stimulator?
The FDA product code for EMS100 Tri-Wave Combination Stimulator is IPF.
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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.