FDA.reportPublic FDA data

STRONGBACK

Primary DI
07640176290299
Brand
STRONGBACK
Company
STRONGBACK MOBILITY USA, LLC
Model
1017+AB/029
Device description
"- Self-proppelled wheelchair- S Model frame (seat depth: 40 cm)- Seat width: 16”/40 cm- Attendant brakes- Quick release rear wheel: 22""/56 cm"
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
07640176290299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640176290299076401762902997640176290299

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 757 349 7790usa@strongbackmobility.com

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
07640176290923STRONGBACK1036+AB/0532024-01-17
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
07640176290367STRONGBACK1016+AB/0362022-08-17

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Primary DI, Brand, Company table
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00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
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