Data / Medical devices / United States / Avazzia, Inc.
Avazzia, Inc.: FDA-registered device maker in Dallas, TX, United States, 7 510(k) clearances
Avazzia, Inc. is registered with the FDA (registration 3004839404) in Dallas, TX, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 27, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004839404
- Address
- 13140 Coit Rd Ste 515, Dallas, TX, United States, 75240
- Owner or operator
- AVAZZIA, INC. (9067759)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 29, 2004
- Registered through
- 2026
- Brand names listed
- Avazzia Blue, Avazzia Lead Wire, AvazziaLife, BEST-PRO1, Best-Pro 1, Biomodulator, Biofeedback Microcurrent BEST-RSI, Conductive Clip, Conductive wrap, conductive garment and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Medical, Therapeutic | MDR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2021 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device | NFO | Substantially Equivalent | Avazzia, Inc. | accessdata.fda.gov |
| May 12, 2017 | K162392 | Avazzia | NUH | Substantially Equivalent | Avazzia, Inc. | accessdata.fda.gov |
| May 23, 2014 | K123099 | Best-AV2 Pro-Sport(tm) | GZJ | Substantially Equivalent | Avazzia, Inc. | accessdata.fda.gov |
| December 18, 2009 | K092546 | GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
| April 30, 2007 | K062641 | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 | GZJ | Substantially Equivalent | Avazzia, Inc. | accessdata.fda.gov |
| December 5, 2005 | K053007 | SKYLARK URO PROBE | KPI | Substantially Equivalent | Skylark Device & Systems Co., Ltd. | accessdata.fda.gov |
| February 2, 2001 | K002219 | WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE | GXY | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 29, 2007 | 38308 | Not yet classified | Terminated | Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Device, Biofeedback
- All makers of Binder, Medical, Therapeutic
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
Updated April 27, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.