FDA.reportPublic FDA data

R82

Primary DI
05707292547026
Brand
R82
Company
R82 A/S
Model
Crocodile, size 3
Catalog number
86803
Published
2020-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707292547026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707292547026057072925470265707292547026

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
308022169
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05715393055838R82x:panda shape infant L, w/belt91020000111042026-03-26
05715393078868R82x:panda shape infant L, no belt90020000030042026-03-26
05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05707292610744R82Cricket SIZE-1870431002022-10-12
05707292610751R82Cricket SIZE-2870432002022-10-12
05715393012275R82Flamingo Curo SIZE-18820012025-09-01
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05707292620989R82Scallop 1991051-1CR21F2022-10-12
05707292620996R82Scallop 1991051-1CR43F2022-10-12
05707292621009R82Scallop 2991051-2CR21F2022-10-12
05707292621016R82Scallop 2991051-2CR43F2022-10-12
05707292621047R82Scallop 3991051-3R21F2022-10-12
05707292621054R82Scallop 3991051-3R43F2022-10-12
05707292621085R82Scallop 4991051-4R21F2022-10-12
05707292621092R82Scallop 4991051-4R43F2022-10-12
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
00815027011867DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027011881DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027012888DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
B845X1021WOTUREIntco Medical Industries, Inc.ITJ2025-08-20
B845X3011WOTUREIntco Medical Industries, Inc.ITJ2025-06-13