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FDA 510(k)

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device

K-Number: K191951 · 2021-04-27

ApplicantAvazzia, Inc.
Decision Date2021-04-27
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is the device name listed in this FDA 510(k) record. The listed applicant is Avazzia, Inc.. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K191951. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Avazzia, Inc.. The 510(k) number is K191951.

When did Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device receive FDA 510(k) clearance?

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device received FDA 510(k) clearance on 2021-04-27, under 510(k) number K191951.

Who is the listed applicant for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

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

What is the FDA product code for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

The FDA product code for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is NFO.

Other records listing Avazzia, Inc. 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.

Related Devices (Code: NFO)

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.

Official Source

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