FDA.reportPublic FDA data

510(k) K240843

Device
GENESIS (MS-P02-GEN)
Applicant
Climbing Steps, Inc.
510(k) number
K240843
Product code
ILK
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-07
Date received
2024-03-27
Regulation
890.5150
Classification name
Transport, Patient, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Barry Fink
Address
1130 E. 24th St. Brooklyn NY US 11210 11210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ILK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222818Xpedition ™ Powered Stair Chair (625700000000)Stryker Medical2023-01-24
K130864C-MAX+ (PLUS)Aat Alber Antriebstechnik GmbH2014-02-06
K121560LEVANT, HOMEGLIDEThyssenkrupp Accessibility B.V.2012-11-01
K121561FLOW2, SWINGThyssenkrupp Accessibility B.V.2012-10-26
K113308BRUNO ELAN STAIRWAY ELEVATORBruno Independent Living Aids, Inc.2012-02-01
K111858LIFTKAR PTSano Transportgeraete GmbH2011-11-04
K103122C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KGAat Alber Antriebstechnik GmbH2010-12-30
K093946HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2Hoveround Corp.2010-03-22
K091858PINNACLE STAIR WAY LIFTSummit Harmar, LLC2009-07-01
K073110MERITS E600 SERIES STAIR LIFTMerits Health Products Co., Ltd.2008-02-06
K033829BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100Bruno Independent Living Aids, Inc.2003-12-29
K033752BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540Bruno Independent Living Aids, Inc.2003-12-12
K033438BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000Bruno Independent Living Aids, Inc.2003-11-20
K032880SUMMIT STAIRWAY LIFTSummit Lifts, Inc.2003-11-10
K023852STAIRFRIEND CURVED STAIRWAY CHAIRLIFTServices Industriels Savaria, Inc.2003-03-04