FDA.reportPublic FDA data

Drive

Primary DI
00822383210681
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
10-65200
Device description
Personal CareAids to Daily Living Product Description: Infrared Heat Wand, Rtl. 1/bx
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383210681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383210681008223832106818223832106810822383210681

GMDN Terms#

Term, Definition table
TermDefinition
Assistive manual gripping tongsA manually-operated device intended to be used by a person with a disability to lengthen (extend) their normal reach to enable them to reach, grasp, and pick-up objects at a distance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04055207069257NARichard Wolf GmbHISA2026-03-12
08809439110623WITHNIXWITHNIX CO.,LTDISA2026-03-06
08809439110630WITHNIXWITHNIX CO.,LTDISA2026-03-06
07630039101909MASTERPULS®Storz Medical AGISA2026-03-01
08057592610676IcooneI-TECH INDUSTRIES SRLISA2026-02-19
08800250280694QuadtheraECO DM LAB Co., Ltd.ISA2026-02-16
06973134771549silverfoxSilverfox Corporation LimitedISA2026-02-05
00851439007135PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007142PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007159PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
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00851439007197PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007203PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00031262120243HomedicsHealth Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.ISA2026-01-15
08806109104555Centellian24 MADECA PRIME RITUAL WHITE PEARLDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
08806109105422Centellian24 MADECA PRIME MAXDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
10810140062892RENPHOJoicom CorporationISA2026-01-04
10810140062861RENPHOJoicom CorporationISA2025-12-16
08436560853152ToskaniTOSKANI SL.ISA2025-12-12
08436560853169ToskaniTOSKANI SL.ISA2025-12-12
10810140062854RENPHOJoicom CorporationISA2025-12-03
06970441320132AquafirmeXSBeijing Anchorfree Technology Co., Ltd.ISA2025-09-23
05391540830833Préime DermaFacialEMA AESTHETICS LIMITEDISA2025-09-15
10810140062670RENPHOJoicom CorporationISA2025-09-11
00860010877487WavonEase Seating SystemsISA2025-09-08