TENS and EMS Stimulator, TENS Stimulator
K-Number: K183074 · 2020-01-11
ApplicantAstek Technology , Ltd.
Decision Date2020-01-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
TENS and EMS Stimulator, TENS Stimulator is a medical device manufactured by Astek Technology , Ltd.. It received FDA 510(k) clearance on 2020-01-11 under approval number K183074. 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 TENS and EMS Stimulator, TENS Stimulator?
TENS and EMS Stimulator, TENS Stimulator is a medical device that received FDA 510(k) clearance on 2020-01-11. It is manufactured by Astek Technology , Ltd.. The 510(k) number is K183074.
When was TENS and EMS Stimulator, TENS Stimulator approved by the FDA?
TENS and EMS Stimulator, TENS Stimulator received FDA 510(k) clearance on 2020-01-11, under approval number K183074.
What company makes TENS and EMS Stimulator, TENS Stimulator?
TENS and EMS Stimulator, TENS Stimulator is manufactured by Astek Technology , Ltd..
What is the FDA product code for TENS and EMS Stimulator, TENS Stimulator?
The FDA product code for TENS and EMS Stimulator, TENS 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.