FDA.reportPublic FDA data

Probasics

Primary DI
00815067013104
Brand
Probasics
Company
Drive Devilbiss Healthcare
Model
X1WC4DAM04
Device description
K4 Deluxe Anti-Tippers
Published
2025-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMRDevice, Anti-Tip, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMRDevice, Anti-Tip, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815067013104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815067013104008150670131048150670131040815067013104

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003767263CustomerService@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
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
00860013569839ValmaxSupply Line MedicalIMR2025-03-20
00193489142078MEDLINEMEDLINE INDUSTRIES, INC.IMR2025-03-10
00199284755567ValmaxSupply Line MedicalIMR2025-02-21
06974231101321ValmaxSupply Line MedicalIMR2025-01-21
00841447114925ADJ REAR ANTI-TIPPER (6)INVACARE CORPORATIONIMR2024-07-25
00810113576640ViveVIVE HEALTH LLCIMR2024-07-17
00860004575641Assembly Required Distributors Inc.Assembly Required Distributors IncIMR2023-07-06
00733657224320ANTI-TIPPER W/C WITH WHEELS PAIRALIMED, INC.IMR2022-12-01
00733657224337ANTI-TIPPER W/C W/O WHEELSALIMED, INC.IMR2022-12-01
00733657286670REAR ANTI-TIPPER W/WHEELS 10/CAALIMED, INC.IMR2022-12-01
00822383157191DriveDrive Devilbiss HealthcareIMR2020-02-11
00822383977799DRIVEDrive Devilbiss HealthcareIMR2020-02-01
00616784026718Wheelchair anti-tipper - For S1, S2 and bariatricDynarex CorporationIMR2019-11-18
00616784026817Wheelchair Anti-tipper for S3, S4Dynarex CorporationIMR2019-11-18
00822383106953DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
00822383112848DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
50822383106958DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
50822383112843DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
00822383972244DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
00822383106922DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383106960DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383106991DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383126265DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383274010DriveDrive Devilbiss HealthcareIMR2017-07-10
50822383106927DriveDrive Devilbiss HealthcareIMR2017-07-10
50822383106965DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383306995DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383121604DriveDrive Devilbiss HealthcareIMR2017-07-10
50822383126260DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383144382DriveDrive Devilbiss HealthcareIMR2017-07-10