FDA.reportPublic FDA data

Comfytopia

Primary DI
00819567017396
Brand
Comfytopia
Company
Comfytopia, Inc.
Model
HMAM0Y0-C110
Device description
HMAM0Y0-C110 CRUTCH
Published
2025-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPSCane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPSCanePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819567017396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819567017396008195670173968195670173960819567017396

GMDN Terms#

Term, Definition table
TermDefinition
Axillary crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003944628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819567011233ComfytopiaSE222025-07-09
00819567011608ComfytopiaFP302025-07-09
00819567011615ComfytopiaFP30 2025-07-09
00819567011639ComfytopiaEP302025-07-09
00819567011646ComfytopiaKP302025-07-09
00819567011660ComfytopiaFS102025-07-09
00819567012452ComfytopiaWS102025-07-09
00819567012469ComfytopiaWS102025-07-09
00819567016818ComfytopiaSE222025-07-09
00819567017839ComfytopiaES102025-07-09
00819567017846ComfytopiaES102025-07-09
00819567017853ComfytopiaFS102025-07-09
00819567017860ComfytopiaFS102025-07-09
00819567017877ComfytopiaFS102025-07-09
00819567017884ComfytopiaFS102025-07-09
00819567017891ComfytopiaKS102025-07-09
00819567017907ComfytopiaKS102025-07-09
00854194003107ComfytopiaWS102025-07-09
00854194003114ComfytopiaES102025-07-09
00854194003121ComfytopiaFS102025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930230BluelineTransparent Supply Solutions Ltd.IPS2026-05-15
00023601017925CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2024-09-09
00810041983336ViveVIVE HEALTH LLCIPS2024-09-04
00810041981837VIVEVIVE HEALTH LLCIPS2024-05-03
00023601015877CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2024-02-22
00057475247348BIOS LivingThermor LtdIPS2023-09-15
00057475247355BIOS LivingThermor LtdIPS2023-09-15
00057475247683BIOS LivingThermor LtdIPS2023-09-15
00057475247751BIOS LivingThermor LtdIPS2023-09-15
00057475247768BIOS LivingThermor LtdIPS2023-09-15
00057475247775BIOS LivingThermor LtdIPS2023-09-15
00057475560164BIOS LivingThermor LtdIPS2023-09-15
00057475560171BIOS LivingThermor LtdIPS2023-09-15
00057475560188BIOS LivingThermor LtdIPS2023-09-15
00057475560225BIOS LivingThermor LtdIPS2023-09-15
00057475247782BIOS LivingThermor LtdIPS2023-03-31
00057475247799BIOS LivingThermor LtdIPS2023-03-31
00057475247805BIOS LivingThermor LtdIPS2023-03-31
00057475247812BIOS LivingThermor LtdIPS2023-03-31
00057475247829BIOS LivingThermor LtdIPS2023-03-31
00057475247836BIOS LivingThermor LtdIPS2023-03-31
00057475247843BIOS LivingThermor LtdIPS2023-03-31
00057475247850BIOS LivingThermor LtdIPS2023-03-31
00057475247867BIOS LivingThermor LtdIPS2023-03-31
00057475247874BIOS LivingThermor LtdIPS2023-03-31
00057475560058BIOS LivingThermor LtdIPS2023-03-31
00057475560119BIOS LivingThermor LtdIPS2023-03-31
00057475560157BIOS LivingThermor LtdIPS2023-03-31
00023601007117CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2023-03-15
00023601007179CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2023-03-15