FDA.reportPublic FDA data

Drive

Primary DI
10822383104475
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
AGF-3E
Device description
TENS Unit,Econ.
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

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
10822383104475PackageGS130In Commercial Distribution
00822383104478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082238310447510822383104475
00822383104478008223831044788223831044780822383104478

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383012155Silver Sport 16" ReclBackSSP16RBDDAV2026-02-03
00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975869140041/Dongguan Bohuikang Technology Co., Ltd.GZJ2026-03-05
06932307410432JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-04
06932307410425JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-03
08032625824480GLOBUSDOMINO SRLGZJ2026-02-23
00714905117649Fab StimCOMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00860163000312CMS COMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00810178880799ViveVIVE HEALTH LLCGZJ2026-02-05
16971712720139KINGPAVONINIHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-01-30
06971760281357EmeTermWAT Medical Technology Inc.GZJ2026-01-23
00092237621967TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-09-29
00860011592808Protocol SolutionsProtocol Solutions LLCGZJ2025-09-05
16971760280050EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280067EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280074EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280081EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280098EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280104EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760281125EmeTermWAT Medical Technology Inc.GZJ2025-08-22
00092237621974TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-08-15
06971760280251EmeTermWAT Medical Technology Inc.GZJ2025-07-31
16971760281071EmeTermWAT Medical Technology Inc.GZJ2025-07-31
00850070096003STIMPOD NMS460ALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096010STIMPOD NMS460 KitALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096027Pulsed Radio Frequency Nerve Stimulation CableALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
30661168800010Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
30661168800027Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000164Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000174Reliefband® FlexRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000188Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
08720618311139Sonopuls 494Enraf-Nonius B.V.GZJ2025-02-11