FDA.report

Wheelchair Front Anti-Tippers

Primary DI
00616784027111
Brand
Wheelchair Front Anti-Tippers
Company
DYNAREX CORPORATION
Model
10271
Device description
Wheelchair Front Anti-Tippers, Pair
Published
2021-04-22
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
KNNComponents, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784027111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784027111006167840271116167840271110616784027111

GMDN Terms

TermDefinition
Wheelchair antitip deviceA device that is added to the front or rear of a wheelchair to prevent upset by limiting the degree of forward or backward tilting that can occur. The device, typically made of metal, may appear as a rod-like arm with or without a wheel at its distal end, and is mounted to the wheelchair in pairs. The device should have sufficient strength to function as intended when the wheelchair is carrying its maximum load on the steepest intended slope.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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