FDA.reportPublic FDA data

CAREX HEALTH BRANDS

Primary DI
30023601013331
Brand
CAREX HEALTH BRANDS
Company
COMPASS HEALTH BRANDS CORP.
Model
FGA33300 0000
Device description
Trio Rolling Walker
Published
2022-12-12
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
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30023601013331PackageGS12In Commercial Distribution
00023601013330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3002360101333130023601013331
00023601013330000236010133300236010133300023601013330

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

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
true
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
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
06975960550749noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-05-25
06975960550701noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-03-24
00810178887392Vive MobilityVIVE HEALTH LLCITJ2026-02-18
00860014768644RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00860014768651RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00810178883882Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178883899Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885206Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885497Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885510Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
04895262504016HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-01-26
00057475820213BIOS LivingThermor LtdITJ2026-01-19
06975960550602noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-15
06975185620166BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDITJ2026-01-07
06975960551470VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06975960551487VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06979196001167RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001174RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001181RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001198RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001204RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001211RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001228RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001235RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001242RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001259RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06975960551463VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2025-12-03