FDA.reportPublic FDA data

Rabbit

Primary DI
05707292436030
Brand
Rabbit
Company
R82 A/S
Model
862232
Device description
Rabbit size 2, 32" wheel, blue
Published
2016-08-17
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

Product Codes#

Code, Name table
CodeName
IPLWheelchair, Standup

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPLWheelchair, StandupPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030882000RABBIT MOBILE STANDING FRAMER82 A/S2003-04-04IPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707292436030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707292436030057072924360305707292436030

GMDN Terms#

Term, Definition table
TermDefinition
Basic walker, non-foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, non-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 in the shape of a mobile support structure which the user holds and pushes in front of them as they walk. It is non-foldable 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
DM exempt
false
Premarket exempt
false
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 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
07613045038841LEVOLEVO AG WohlenIPL2026-02-26
07613045036762LEVOLEVO AG WohlenIPL2025-09-09
07613045038940LEVOLEVO AG WohlenIPL2025-09-09
07613045071503LEVOLEVO AG WohlenIPL2025-09-09
09356399060974Magic XT2RED MILAWA PTY. LTD.IPL2024-11-18
17330818002003PermobilPERMOBIL, INC.IPL2023-08-15
17330818000993PermobilPERMOBIL, INC.IPL2023-07-07
07540147011444MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
07540147011451MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
00811478030013Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030020Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030037Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030044Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030051Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030068Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030075Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00016958059793Quickie Q700-UP M / Q700MSUNRISE MEDICAL (US) LLCIPL2021-05-03
04064406193656Paragolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2020-09-15
00810058400031Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400048Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400055Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00859706005976Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00811478030006Tek Robotic Mobilization DeviceMatia Robotics (us), Inc.IPL2018-03-21
B289SS1F0SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2017-01-30
00863444000308Redman/Chief Power ChairCHIEF POWER CHAIR, LLCIPL2016-12-19
08680905006905TEK Robotic Mobilization DeviceMATIA ROBOTICS MEKATRONIK SISTEMLER AR-GE MUHENDISLIK YAZILIM SANAYI VE TICARET A SIPL2016-09-25
B289HPS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289PS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289SS1SuperStand STANDING COMPANY, THEIPL2016-09-24
04032767048397ParaGolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15