FDA.reportPublic FDA data

Avazzia

Primary DI
00851530007645
Brand
Avazzia
Company
AVAZZIA INC
Model
A4-TB OTC
Catalog number
A4-TB-OTC
Device description
Tennant Biomodulator Plus OTC with instruction manual and batteries
Published
2026-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851530007645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851530007645008515300076458515300076450851530007645

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Regulatory Flags#

DUNS number
603638607
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851530007829AvazziaAA-LW-4P-250F-60KAA-LW-4P-250F-60K2026-04-24
00851530007621AvazziaA4-EBA4-EB2026-04-21
00851530007638AvazziaA4-EB-KA4-EB-K2026-04-21
00851530007881AvazziaA4-TB2A4-TB22026-04-21
00851530007898AvazziaA4-PLA4-PL2026-04-21
00851530007904AvazziaA4-PL-KA4-PL-K2026-04-21
00851530007744AvazziaA4-AG OTCA4-AG OTC2020-07-15
00851530007751AvazziaA4-AG-K-Y OTCA4-AG-K-Y OTC2020-07-15
00851530007768AvazziaA4-AG-K OTCA4-AG-K OTC2020-07-15
00851530007034AvazziaA4-ALA4-AL2016-09-23
00851530007102AvazziaA4-TBA4-TB2016-09-23
00851530007225AvazziaAA-USAA-US2016-09-23
00851530007232AvazziaAA-URAA-UR2016-09-23
00851530007256AvazziaA4-EN-KA4-EN-K2016-12-19
00851530007287AvazziaAA-CP-FaceAA-CP-Face2016-09-23
00851530007294AvazziaAA-CP-EyeAA-CP-Eye2016-09-23
00851530007300AvazziaAA-CG-GloveAA-CG-Glove2016-09-23
00851530007317AvazziaAA-CG-SockAA-CG-Sock2016-09-23
00851530007324AvazziaAA-CG-ArmAA-CG-Arm2016-09-23
00851530007331AvazziaAA-CG-LegAA-CG-Leg2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NUH2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNUH2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NUH2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNUH2025-08-15
00850073128107AVCOOADP HEALTH LIMITEDNUH2025-07-02
00850073128091AVCOOADP HEALTH LIMITEDNUH2025-05-26
00810038637365easy@Home TENS AND MUSCLE STIMULATOREASY HEALTHCARE CORPORATIONNUH2025-04-17