FDA.reportPublic FDA data

Avazzia

Primary DI
00851530007904
Brand
Avazzia
Company
AVAZZIA INC
Model
A4-PL-K
Catalog number
A4-PL-K
Device description
Convenience kit with Avazzia Life Pinnacle Lite device, conductive pads, Brush electrode, Y electrode, lead wires, and carry case.
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851530007904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851530007904008515300079048515300079040851530007904

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
Kit
true
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
00851530007645AvazziaA4-TB OTCA4-TB-OTC2026-03-31
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
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17
00815290019416ePower® T2 DIGITAL TENSCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17
00815290019423ePower® TE2 COMBO TENS & EMSCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17
00092237624456Richmar EMG ProDrive Devilbiss HealthcareGZJ2023-08-03
00815290019232ePower®CLINICAL HEALTH SERVICES, INC.GZJ2023-07-15
00815290019249ePower®CLINICAL HEALTH SERVICES, INC.GZJ2023-07-15
00190446780601CHATTANOOGADJO, LLCGZJ2023-04-25
00190446780618CHATTANOOGADJO, LLCGZJ2023-04-25