510(k) Report

FDA applicant

Avazzia, Inc.

Dallas, TX4 decisions2007–20213 recalls

FDA records 4 decisions for Avazzia, Inc. (Dallas, TX) from 2007 to 2021: 4 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and NFO (Stimulator, Transcutaneous Electrical…). Its devices cite 5 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Avazzia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12014: 12017: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Avazzia, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avazzia, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 20212cite it
  • K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 20072cite it

What has FDA decided for it lately?

  • K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
  • K162392AvazziaAvazzia, Inc. · 2017
  • K123099Best-AV2 Pro-Sport (tm)Avazzia, Inc. · 2014
  • K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 20073 recalls

All 4 as Avazzia, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K062641Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by…Jun 29, 2007
  • K062641Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc.…Jun 29, 2007
  • K062641Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia…Jun 29, 2007