Avazzia

FDA 510(k) K162392 · Avazzia, Inc.

Substantially Equivalent

510(k) numberK162392

Submission

Device name
Avazzia
Applicant
Avazzia, Inc.
Dallas, TX, US
Received
August 26, 2016
Decision date
May 12, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

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K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceNFO · Traditional 04/27/2021SE
K123099Best-AV2 Pro-Sport(tm)GZJ · Traditional 05/23/2014SE
K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model BEST-AV1GZJ · Traditional 04/30/2007SE

Questions and answers

When was Avazzia cleared by the FDA?

Avazzia (K162392) received a 510(k) decision of Substantially Equivalent on May 12, 2017, 259 days after the submission was received.

What is the product code of K162392?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.