FDA.reportPublic FDA data

HEADALOFT360

Primary DI
07290016145168
Brand
HEADALOFT360
Company
HEADOVATIONS LTD
Model
UFHS-001
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMSSupport, Head And Trunk, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016145168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016145168072900161451687290016145168

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649092368
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016145236HEADALOFTHAOS-0012023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004033Side Mount Headrest Interface PlateMotion Concepts IncIMS2026-05-19
10194484321953CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322059CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322073CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322080CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322097CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322103CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
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10194484322165CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
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10194484322233CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322240CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322257CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22