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AVAZZIA, INC.

USA · Dallas

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 2Class II 8Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 3IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: AVAZZIA, INC.

FDA 510(k) clearances by year

12007 · K062641

12014 · K123099

12017 · K162392

12021 · K191951

FDA listed device types

showing 8 of 10

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Cable, Electrode 1Light Based Over The Counter Wrinkle Reduction 1Electrode, Cutaneous 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Device, Biofeedback 1

Market	Identifier	Name	Class / date
US	K191951	Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device	2021-04-27
US	K162392	Avazzia	2017-05-12
US	K123099	Best-AV2 Pro-Sport(tm)	2014-05-23

AVAZZIA, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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