FDA.reportPublic FDA data

PerfectFit Standard Rollator

Primary DI
00860001638721
Brand
PerfectFit Standard Rollator
Company
Carrier Medical LLC
Model
PF920
Catalog number
PF920
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860001638721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001638721008600016387218600016387210860001638721

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.

Regulatory Flags#

DUNS number
080542410
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
00860001638783PerfectFit Heavy Duty RollatorPFHD930PFHD9302026-07-13
00860001638790Phantom Knee WalkerKWBK900KWBK9002026-07-13
00860014392702ICON Heavy Duty RollatorICONHD811ICONHD8112026-07-13
00860014392719ICON Standard RollatorICON711ICON7112026-07-13
00860014392726AirLite Standard RollatorARL820ARL8202026-07-13
00860014392733Standard Offset CaneCBK57CBK572026-07-13
00860014392740Heavy Duty Offset CaneHCBK121HCBK1212026-07-13
00860014392757ICON Oxygen Tank HolderOTH1400OTH14002026-07-13
00860014392764PerfectFit Oxygen Tank HolderOTH7000OTH70002026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001638783PerfectFit Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860001638790Phantom Knee WalkerCarrier Medical LLCITJ2026-07-13
00860014392702ICON Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860014392719ICON Standard RollatorCarrier Medical LLCITJ2026-07-13
00860014392726AirLite Standard RollatorCarrier Medical LLCITJ2026-07-13
04719876190253TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.ITJ2026-07-08
00194346283439EquateDrive Devilbiss HealthcareITJ2026-06-10
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22