FDA.reportPublic FDA data

Permobil

Primary DI
17330818000993
Brand
Permobil
Company
PERMOBIL, INC.
Model
Explorer Mini
Published
2023-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K190682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190682000Explorer MiniPermobil AB2020-02-27IPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17330818000993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1733081800099317330818000993

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606896405
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17330818001334PermobilM300 Corpus HDM300 Corpus HD2024-04-10
17330818123456PermobilC3502016-08-12
17330818123401PermobilM300M300 PS Junior2016-08-12
17330818002003PermobilM Corpus VS2023-08-15
17330818229844PermobilF5F5 Corpus2016-08-12
17330818001006PermobilF5 VSF5 Corpus VS2019-11-12
17330818198768PermobilM4002016-08-12
17330818889420PermobilC300K300 PS Junior2016-08-12
17330818252316PermobilM12017-08-09
17330818334562PermobilM52017-03-01
17330818345674PermobilM32017-01-01
17330818555783PermobilKoala2016-08-12
17330818676433PermobilF32016-08-12
17330818786507PermobilK4502016-08-12
17330818252319PermobilM12017-08-09

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
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
04032767402526ParaGolfer Power wheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15