FDA.report

R82

Primary DI
05707292604064
Brand
R82
Company
R82 A/S
Model
Mustang SIZE-3
Catalog number
869033
Published
2022-10-12
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
ITJWALKER, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707292604064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707292604064057072926040645707292604064

GMDN Terms

TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient 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 patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Sterilization Methods

Method

Regulatory Flags

DUNS number
308022169
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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05715393012275R82Flamingo Curo SIZE-18820012025-09-01
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15
05715393021956R82Crocodile, Size 2 AT86802AT2025-05-15
05715393021963R82Crocodile, Size 3 AT86803AT2025-05-15
05715393021970R82Crocodile, Size 1 AT86801AT-ATS2025-05-15
05715393021987R82Crocodile, Size 2 AT86802AT-ATS2025-05-15
05715393022014R82Crocodile, Size 3 AT86803AT-ATS2025-05-15
05715393013982R82Meerkat SIZE-1870011-1RS2024-09-13
05715393013999R82Meerkat SIZE-1870011-2RS2024-09-13
05715393014002R82Meerkat SIZE-2870022-RS2024-09-13
05715393014019R82Meerkat SIZE-3870023-RS2024-09-13
05707292975003R82Chilla SIZE 18811111002024-08-14
05707292975027R82Chilla SIZE 18811111102024-08-14
05707292975041R82Chilla SIZE 18811111202024-08-14

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00860014768644RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00860014768651RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00810178883882Vive MobilityVIVE HEALTH LLCITJ2026-02-03
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00810178885206Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885497Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885510Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
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