FDA.reportPublic FDA data

Probasics

Primary DI
00815067013319
Brand
Probasics
Company
Drive Devilbiss Healthcare
Model
X1WC4DAM19
Device description
K4 Deluxe Replacement Armrest, Pair
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
IMLArmrest, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMLArmrest, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815067013319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815067013319008150670133198150670133190815067013319

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
00841447115854Freedom Designs™ Recover Armrest PadsINVACARE CORPORATIONIML2025-10-27
00841447115861Freedom Designs™ Armrest Pads OnlyINVACARE CORPORATIONIML2025-10-27
00841447115922Freedom Designs™ Arm Trough with T-NutsINVACARE CORPORATIONIML2025-10-27
00841447115939Freedom Designs™ Arm Trough with Multi Axial HardwareINVACARE CORPORATIONIML2025-10-27
00197344014623MEDLINEMEDLINE INDUSTRIES, INC.IML2025-05-07
10197344033485MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
80197344033484MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
10193489188127MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188134MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188141MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188165MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
00197344014555MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80197344014551MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188126MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188133MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188140MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188164MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489187939MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187953MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187960MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
00810113576909Vive MobilityVIVE HEALTH LLCIML2024-09-04
10810113576906Vive MobilityVIVE HEALTH LLCIML2024-09-04
00841447114949KIT ARMPAD FULL W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
00841447114956KIT ARMPAD DESK W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
10197344033478MEDLINEMEDLINE INDUSTRIES, INC.IML2024-06-20
00197344014562MedlineMEDLINE INDUSTRIES, INC.IML2024-04-11
00197344014647GuardianMEDLINE INDUSTRIES, INC.IML2024-03-05
10193489188264MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16
20193489188261MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16
10193489187946GuardianMEDLINE INDUSTRIES, INC.IML2023-12-21