FDA.report

NA

Primary DI
00842307101994
Brand
NA
Company
GENDRON, INC.
Model
6722-18-61-78-29-8
Device description
WHEELCHAIR,22X18DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000
Published
2017-05-05
Public version status
Update
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
INMChair, With Casters

Product Code Classifications

CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842307101994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307101994008423071019948423071019940842307101994

GMDN Terms

TermDefinition
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is 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

Regulatory Flags

DUNS number
054164587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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