FDA.reportPublic FDA data

Probasics

Primary DI
00815067078554
Brand
Probasics
Company
COMPASS HEALTH BRANDS CORP.
Model
WC4L1816DE
Device description
ProBasics K4 Lite Wheelchair 18"x16" Height Adjustable, Flip Back, Desk-Length, Elevating Footrests
Published
2023-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815067078554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815067078554008150670785548150670785540815067078554

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840363375540KiKI MOBILITY, LLCIOR2026-03-11
00810178884506ViveVIVE HEALTH LLCIOR2026-03-06
00810178885213ViveVIVE HEALTH LLCIOR2026-03-06
00810178885220ViveVIVE HEALTH LLCIOR2026-03-06
00810178885237ViveVIVE HEALTH LLCIOR2026-03-06
00840117408661ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408678ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408685ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408692ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408708ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408715ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408722ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
04719873857104KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
04719873857395KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
00841447116301Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116318Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116325Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116332Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116349Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116356Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116363Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116370Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116387Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116394Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116400Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116417Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00840117408180ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408197ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408203ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408210ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05