FDA.report

Sleek Motion 22lb.X-Light Wheelchair with Footrest,18"

Primary DI
00840117334656
Brand
Sleek Motion 22lb.X-Light Wheelchair with Footrest,18"
Company
DYNAREX CORPORATION
Model
10282
Published
2024-07-24
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

Related Records

Product Codes

CodeName
IORWheelchair, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117334656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117334656008401173346568401173346560840117334656

GMDN Terms

TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or 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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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