FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383985411
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
SK4146
Device description
PowerAccessories Product Description: Phoenix HD4 Shroud Kit - Pear, 1/pkg
Published
2019-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNNCOMPONENTS, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383985411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383985411008223839854118223839854110822383985411

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant-controlled, manual-steering, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and manual control of direction is performed by an attendant. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077026587EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-15
06972077026365EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026372EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026389EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026396EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026457EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026464EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026471EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026488EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026495EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026334EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026358EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082689077Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082695511Spex SeatingSPEX LIMITEDKNN2026-04-30
06934726614484Battery ChargerLongfian Scitech Co., Ltd.KNN2026-04-25
10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
05407008321222mo-vismo-VisKNN2025-11-19
05407008321239mo-vismo-VisKNN2025-11-19
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051725195Spex LimitedSPEX LIMITEDKNN2025-11-07