FDA.reportPublic FDA data

Skippi

Primary DI
04032767048243
Brand
Skippi
Company
Otto Bock Mobility Solutions GmbH
Model
490E55=00000
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070318000SKIPPI POWERED WHEELCHAIR FOR CHILDRENOtto Bock Healthcare LP2007-05-11ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04032767048243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04032767048243040327670482434032767048243

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341148586
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04032767034376Arm Support Offset Plate436H1=72024-04-09
04032767350711Kit for nut-modular armrest437A402024-04-09
04032767358595Heavy Duty Clamp complete, Black477L52=SK0552024-04-09
04064406193656Paragolfer Power Wheelchair490E54=00000_K2020-09-15
04064406089836Clinical Assembly Set (43-53cm), Black476D52=SK0152023-12-19
04064406089850Clinical Assembly Set (54-64cm), Black476D52=SK0252023-12-19
04064406089874Assembly Set (18-42 cm), Black476D52=SK0352023-12-19
04064406089898Assembly Set (40-54 cm), Black476D52=SK0452023-12-19
04064406089911Assembly Set (52-62 cm), Black476D52=SK0552023-12-19
04064406089935Clinical Assembly Set (38-42cm), Black476D52=SK0652023-12-19
04064406090221Head Support Mounting Hardware Multi-Crank, Black476L52=SK0152023-12-19
04064406090245Head Support Mounting Hardware Multi-Straigt, Black476L52=SK0252023-12-19
04064406065755"Clamp, 1"", Black"434H1=1-72023-12-19
04064406065779S.T.S. Clamp 3/4 Inch Black434H1=3/4-72023-12-19
04064406065793S.T.S. Clamp 7/8 Inch Black434H1=7/8-72023-12-19
04064406066592Channel Forearm Pad, Large436A2=1-72023-12-19
04064406066608Channel Forearm Pad, Medium436A2=2-72023-12-19
04064406066615Channel Forearm Pad, Small436A2=3-72023-12-19
04064406066622Channel Arm Support One Piece436A3=2-72023-12-19
04064406066752Hand Pad Palm Extenser436P2=L1-72023-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
06976245010378Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09