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510(k) K120302

Device
MECHANICAL WHEELCHAIR
Applicant
NOVAF ANDALUCIA 2007, SL
510(k) number
K120302
Product code
IQC  
Decision
Substantially Equivalent (SESE)
Decision date
2012-07-06
Date received
2012-02-01
Regulation
890.3880
Classification name
Wheelchair, Special Grade
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FERNANDO SAENZ DE SANTAMARIA
Address
Camino SE Santa Teresa Nave 1 Rota ES PC 11520 PC 11520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251570Hippocampe Marathon and TrailVipamat Sarl2025-06-23
K082857RENEGADE WHEELCHAIRAlpha One2009-01-06
K051709HIPPOCAMPE WHEELCHAIRVipamat Technologie2005-08-15
K895384CALIFORNIA COMFORT FOUR WHEELJubilee Scooters, Inc.1989-09-18
K861943PCI CUSTOM DESIGN SERIESPoston & Cole Intl.1986-05-30
K843213QUALINE WHEELCHAIR PRODUCTSContemporary Health Sys1984-08-24
K842719STANDARD WHEELCHAIRGreene International Corp.1984-07-25
K840234POIRIER VARIABLE WHEELCHAIRPoirier S.A.1984-02-27
K840625UNION WHEELCHAIRPoirier S.A.1984-02-27
K840627AMPUTEE WHEELCHAIRPoirier S.A.1984-02-27
K840628LARGE FRONT WHEELS WHEELCHAIRPoirier S.A.1984-02-27
K840630POIRIER REGLADE WHEELCHAIRPoirier S.A.1984-02-27
K840631ARNAS WHEELCHAIRPoirier S.A.1984-02-27
K840632HEMIPLEGIC WHEELCHAIRPoirier S.A.1984-02-27
K840634OLYMPIC & BASKET WHEELCHAIRSPoirier S.A.1984-02-27

Legacy Summary#

summary

FDA Review#

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