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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Astek Technology , Ltd.. It received FDA 510(k) clearance on 2020-01-11 under 510(k) 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. The listed applicant is Astek Technology , Ltd.. The 510(k) number is K183074.

When did TENS and EMS Stimulator, TENS Stimulator receive FDA 510(k) clearance?

TENS and EMS Stimulator, TENS Stimulator received FDA 510(k) clearance on 2020-01-11, under 510(k) number K183074.

Who is the listed applicant for TENS and EMS Stimulator, TENS Stimulator?

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

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.

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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