FDA.report

CAREX HEALTH BRANDS

Primary DI
30023601005152
Brand
CAREX HEALTH BRANDS
Company
COMPASS HEALTH BRANDS CORP.
Model
FGA51500 BLUE
Device description
DESIGNER OFFSET CANE - BLUE
Published
2022-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IPSCane

Product Code Classifications

CodeDeviceSpecialtyClass
IPSCanePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30023601005152PackageGS12In Commercial Distribution
00023601005151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3002360100515230023601005152
00023601005151000236010051510236010051510023601005151

GMDN Terms

TermDefinition
Single-base walking stickA rod, typically made of wood or metal, with one leg/foot and a handgrip or curved handle and without forearm support used to assist a person with a disability to maintain their balance and support their weight while walking. It may be of fixed or adjustable length, and collapsible or non-collapsible.

Sterilization Methods

Method

Contacts

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
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

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00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
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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

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Primary DIBrandCompanyProduct codePublished
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00810178884490Vive MobilityVIVE HEALTH LLCIPS2025-09-25
00818323025422Vive MobilityVIVE HEALTH LLCIPS2025-09-25
00815027012741DALTON QUAD CANEDALTON MEDICAL CORPORATIONIPS2025-09-18
06972223254390CaneFoshan Shunkangda Medical Tech Co.,LtdIPS2025-07-11
30023601017100CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.IPS2025-05-21
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00819567017396ComfytopiaComfytopia, Inc.IPS2025-02-23
00854194003015ComfytopiaComfytopia, Inc.IPS2025-02-23
30023601017926CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.IPS2024-09-09
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10850041211395VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211401VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211418VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211432VIVEVIVE HEALTH LLCIPS2024-07-17
10810041981834VIVEVIVE HEALTH LLCIPS2024-05-03
10810113576746ViveVIVE HEALTH LLCIPS2024-05-03
10810113576166ViveVIVE HEALTH LLCIPS2024-03-08
10810113576173ViveVIVE HEALTH LLCIPS2024-03-08
10810113574254ViveVIVE HEALTH LLCIPS2024-01-05
10810113574261ViveVIVE HEALTH LLCIPS2024-01-05
10810113574346ViveVIVE HEALTH LLCIPS2024-01-05
10818323021247ViveVIVE HEALTH LLCIPS2023-11-13
10057475247345BIOS LivingThermor LtdIPS2023-09-15
10057475247352BIOS LivingThermor LtdIPS2023-09-15
10057475247680BIOS LivingThermor LtdIPS2023-09-15
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