FDA.report

DynaGo Quad 6 - (Red) Aluminum Rollator with 6" Wheels

Primary DI
00616784020143
Brand
DynaGo Quad 6 - (Red) Aluminum Rollator with 6" Wheels
Company
DYNAREX CORPORATION
Model
10201RD
Published
2019-11-07
Public version status
Update
Distribution status
Not 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
ITJWalker, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784020143PrimaryGS10

GMDN Terms

TermDefinition
Basic walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and four or three legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable and some types may include a seat on which the user can rest.

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
true
Serial number
false
Manufacturing date on label
true
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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