ITI

Product Code: ITI


Products Classified as ITI

5187Wheelchair, PoweredPowered Wheelchair.

Total Product Life Cycle (TPLC) Devices

5187Wheelchair, PoweredPowered Wheelchair.

FDA Consensus Standards

Wheelchair, Powered [33614]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31940]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [33526]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31935]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [38697]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31914]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31052]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [37770]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31939]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31931]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [37769]21 CFR §890.3860 ๐Ÿ”Ž
Wheelchair, Powered [31911]21 CFR §890.3860 ๐Ÿ”Ž

Pre-market Notifications for ITI

K193599BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair21st Century Scientific, Inc.
K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation
K192016SMOOV O10Alber GmbH
K182995Bariatric Power Positioning System (BPPS)Motion Concepts
K182946Invacare TDX SP2-HD With Captain's SeatInvacare Corporation
K182576Solax Powered WheelchairDongguan Prestige Sporting Goods Co., Ltd
K182400Solax Powered Wheelchair (Models: S7101, S7103)Dongguan Prestige Sporting Goods Co., Ltd
K181908Action TrackchairAction Manufacturing Inc.
K181163Wu's Powered WheelchairWu's Tech Co., Ltd.
K173315SupaChair Powered WheelchairEurogreen International Inc.
K173313SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SPEurogreen International Inc.
K170787Powered Wheelchair DYW30A(D09)Nanjing Jin Bai He Medical Apparatus Co., Ltd.
K170507Invacareยฎ TDXยฎ SP2 Power Wheelchair; TDXSP2 TDX SP2 With LiNX Electronics, TDXSP2-CG TDX SP2 Base For Single Act. System W/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base For Multiple Actuator System W/ Ultra Low MaxxInvacare Corporation
K163204A08 Power WheelchairKunshan Aoshida Electric Technology Co., Ltd
K161241E-fix E35/E36Alber GmbH

Global Unique Device Identification Database

00606509200165Wheelchair, Powered
00606509200158Wheelchair, Powered
00606509200141Wheelchair, Powered
00606509200134Wheelchair, Powered
00606509200127Wheelchair, Powered
00606509200110Wheelchair, Powered
00606509200103Wheelchair, Powered
00606509200097Wheelchair, Powered
00606509200080Wheelchair, Powered
00606509200073Wheelchair, Powered
00606509200066Wheelchair, Powered
00606509200059Wheelchair, Powered
00606509200042Wheelchair, Powered
00606509200035Wheelchair, Powered
00606509200028Wheelchair, Powered

Maude Adverse Events

HOVEROUNDHOVEROUND CORPORATION2020-03-31
PERMOBIL M3PERMOBIL INC.2020-03-30
POWERED WHEELCHAIR SYSTEMMOTION CONCEPTS LP2020-03-24
PERMOBIL M3PERMOBIL INC.2020-03-23
PERMOBIL C500PERMOBIL AB (PAB)2020-03-19
PERMOBIL M300PERMOBIL INC.2020-03-19
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-03-18
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-03-18
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-03-18
POWERED WHEELCHAIR SYSTEMMOTION CONCEPTS LP2020-03-13
POWERED WHEELCHAIR SYSTEMMOTION CONCEPTS LP2020-03-12
HOVEROUNDHOVEROUND CORPORATION2020-03-09
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-03-05
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-03-05
PERMOBIL C300PERMOBIL INC.2020-03-04
PERMOBIL M3PERMOBIL INC.2020-03-04
PERMOBIL POWER WHEELCHAIRPERMOBIL2020-02-26
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-21
PERMOBIL M300PERMOBIL INC.2020-02-19
F5 CORPUS VSPERMOBIL AB (PAB)2020-02-18
TDX SP2INVACARE TAYLOR ST.2020-02-18
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-18
PERMOBIL F3PERMOBIL INC.2020-02-17
PERMOBIL M300PERMOBIL INC.2020-02-14
PERMOBIL F5PERMOBIL INC.2020-02-13
3G TORQUE 3 WITH FORMULA CG SEATINGINVACARE TAYLOR STREET2020-02-12
PERMOBIL F5PERMOBIL AB (PAB)2020-02-12
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-12
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-12
PERMOBIL M3 CORPUS POWER WHEELCHAIRPERMOBIL, INC.2020-02-10
HOVEROUNDHOVEROUND CORPORATION2020-02-10
E-MOTION M15ALBER GMBH2020-02-10
PERMOBIL M3 CORPUSPERMOBIL INC.2020-02-07
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-06
PERMOBIL F5PERMOBIL INC.2020-02-05
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-05
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-05
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-02-05
PERMOBIL M3 CORPUSPERMOBIL INC.2020-02-03
PERMOBIL F5PERMOBIL INC.2020-01-31
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-01-27
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-01-27
QUICKIE Q500MSUNRISE MEDICAL (US) LLC2020-01-23
PERMOBIL C500PERMOBIL INC.2020-01-22
TDX SP2 BASE FOR MULTIPLE ACTUATOR SYSTEM W/ ULTRA LOW MAXXINVACARE TAYLOR STREET2020-01-20
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-01-20
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-01-16
QUICKIE PULSE 5 POWERCHAIRSUNRISE MEDICAL (US) LLC2020-01-15
TDX SP2 BASE FOR REHAB SEATINGINVACARE TAYLOR STREET2020-01-15
PRIDE MOBILITY PRODUCTSPRIDE MOBILITY PRODUCTS2020-01-15

ยฉ 2020 FDA.report
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