Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IPL — Predicate Candidate Screening

66 FDA 510(k) clearances under this product code; the 50 most recent screened below.

85 daysmedian FDA review time
378 days90th percentile
66clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243783Walking rehabilitation training electric wheelchair (ZW518)Shenzhen Zuowei Technology Co., Ltd.2025-03-12930
K202728Action Trackchair HawkAction Manufacturing, Inc.2022-02-105100
K203761ParaMotionPowerbasetec GmbH2022-01-213940
K191334Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03Matia Robotics (Us), Inc.2020-05-293780
K190682Explorer MiniPermobil AB2020-02-273460
K191874F5 Corpus VSPermobil AB2019-10-251050
K182257UPnRIDEUpnride Robotics , Ltd.2019-09-123870
K191376Modular Power Standing SystemMotion Concepts2019-08-13820
K172384Quickie(r) Q700-UP MSunrise Medical (Us), LLC2018-01-161610
K163451Action Trackstander models TR1816, TR1820, TR2016, and TR202Action Manufacturing, Inc.2018-01-124000
K150548Tek RMD (Tek Robotic Mobilization Device)Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S2015-06-111000
K122562E-TENG MODEL EOR 1E-Teng Technology, Inc.2013-08-093520
K102837HIROLLER ELEVATING WHEELCHAIRMax Mobility, LLC2010-12-23850
K102734COMFORT STANDING WHEELCHAIR, HERO SERIESComfort Orthopedic Co., Ltd.2010-12-14830
K090256POWER STANDING DANIDavismade, Inc.2009-07-061540
K083017LEVO C3Levo AG2008-10-24150
K072475BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UPEtac Sverige AB2007-12-211080
K071761LLOYD LINDEN, MODEL E04Lloyd Linden, Inc.2007-08-03350
K071390WHEELCHAIR MODEL STSInnovative Products, Inc.2007-07-20630
K061726LSC, MODEL 3Lifestand2006-12-041680
K060936PARAGOLFERParabasetec, GmbH2006-08-071240
K052375ALILIFE STAND UP POWERED WHEELCHAIR, HC-300Alilife Technological Co., Ltd.2005-09-09100
K051387LEVO COMFORT IILevo AG2005-06-10140
K042596LSA HELIUMLifestand2005-01-261250
K041535LSC LIFESTAND COMPACTLifestand2004-09-161000
K032101POWERSTAND STAND-UP WHEELCHAIRThe Standing Co., Inc.2004-01-221981
K031621HERO 1, MODEL LY-ESB220Comfort Orthopedic Co., Ltd.2004-01-222440
K031618COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2Comfort Orthopedic Co., Ltd.2003-12-182090
K030882RABBIT MOBILE STANDING FRAMER82 A/S2003-04-04150
K030893LEVO COMBILevo AG2003-04-02120
K021165NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08Bromac Assistive Technology2002-07-01810
K011530VERTRAN STANDING WHEELCHAIRFena Design, Inc.2001-10-161520
K012345NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIRBromac Assistive Technology2001-10-03710
K994083STANNAH POWER CHAIR, MODEL 201Stannah Power Chairs , Ltd.2001-04-044880
K984391THE LIBERATORLiberator Wheelchairs, Inc.1999-09-032690
K973951LEVO COMPACT-EASY LCELevo USA1997-12-23680
K963817LEVO MOBIL LCMLevo USA1997-12-234560
K971873LEVO ACTIVE-EASY LAELevo USA1997-07-03440
K970543BOBCAT DXQuest Enabling Designs , Ltd.1997-06-261340
K963816LEVO COMPACT LCLevo USA1996-10-30370
K962278SUPERSTAND STAND-UP WHELLCHAIRThe Standing Co., Inc.1996-10-021110
K940919CHIEF SRRedman, Inc.1995-02-033440
K940852CHIEF STANDUP WHEELCHAIRRedman, Inc.1995-02-033450
K946110REGAIN STAND-UP WHEELCHAIRRegain, Inc.1995-02-01490
K943129ECONOSTANDSf Research Corp.1994-11-171410
K943337STANDUP WHEELCHAIRNestor Rehab Products , Ltd.1994-08-09280
K924314MOBILE STANDING FRAMEMetatech Corp.1993-02-121700
K922107TAYLOR MADE MOBILE STANDERNelson A. Taylor Co., Inc.1992-05-26210
K921894RIFTON MOBILE PRONE STANDERSRifton Equipment For the Handicapped1992-05-26340
K921084THE EXCELSIORRehab Technology, Inc.1992-04-07320

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda