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510(k) K926170

Device
STEPMILL EXERCISE SYSTEM
Applicant
STAIRMASTER SPORTS/MEDICAL PRODUCTS, INC.
510(k) number
K926170
Product code
ISD  
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-31
Date received
1992-11-23
Regulation
890.5360
Classification name
Exerciser, Measuring
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
DON WIPF
Address
10757 E. Ute St. Tulsa OK US 74116 74116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ISD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.2020-12-21
K183296REAL Immersive SystemPenumbra, Inc.2019-03-18
K143512ActiSpec Activity MonitorSleep Modus, Inc.2015-08-26
K112121ERGOSELECT/GEErgoline GmbH2012-10-31
K080545ACTITRAINERActigraph, LLC2008-07-24
K053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbH2006-04-27
K990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.1999-04-29
K990813REHCORElectromed Corp.1999-04-12
K962855ULE-2, MULE-2, HAND ACCESSORY KITPenny and Giles Biometrics , Ltd.1996-12-11
K952163DAVID BACK CLINIC SYSTEMKinetic Resources, Inc.1996-08-12
K941033PHYSIO HABLongo Industries1995-02-27
K940065SES100Southwest Ergonomics1994-12-06
K934238MULEPenny and Giles Biometrics , Ltd.1994-10-26
K930735LORDEX LUMBAR EXTENSION MACHINELordex, Inc.1994-09-29
K933611THE BTE WS30Baltimore Therapeutic Equipment Co.1994-06-20

Legacy Summary#

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FDA Review#

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