FDA.reportPublic FDA data

STRONGBACK

Primary DI
07640176290923
Brand
STRONGBACK
Company
STRONGBACK MOBILITY USA, LLC
Model
1036+AB/053
Device description
- Self-proppelled wheelchair- Seat width: 22”/55 cm- Drum brakes- Quick release rear wheel: 24”/61 cm- Solid armrests
Published
2024-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640176290923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640176290923076401762909237640176290923

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, bariatricA non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person without the full capacity to walk to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040262426
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640176291265STRONGBACKSEATA Rollator2024-01-17
07640176290015STRONGBACK1017/0012022-08-17
07640176290022STRONGBACK1007/0022022-08-17
07640176290039STRONGBACK1010/0032022-08-17
07640176290084STRONGBACK1019/0082022-08-17
07640176290169STRONGBACK1002/0162022-08-17
07640176290183STRONGBACK1003/0182022-08-17
07640176290206STRONGBACK1003+AB/0202022-08-17
07640176290237STRONGBACK1007+AB/0232022-08-17
07640176290244STRONGBACK1010+AB/0242022-08-17
07640176290268STRONGBACK1012+AB/0262022-08-17
07640176290299STRONGBACK1017+AB/0292022-08-17
07640176290367STRONGBACK1016+AB/0362022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00822383037165Cruiser 3 18"Drive Devilbiss HealthcareIOR2026-06-22
00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
06970006394691DAYANG MEDICALGuangdong Dayang Medical Technology Co.,LtdIOR2026-06-10
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