FDA.reportPublic FDA data

510(k) K202979

Device
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
Applicant
Lode B.V.
510(k) number
K202979
Product code
ISD
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-21
Date received
2020-09-30
Regulation
890.5360
Classification name
Exerciser, Measuring
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Abbreviated
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
J.R. Fransens
Address
Zernikepark 16 Groningen NL 9747 AN 9747 AN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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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
K926278STAIR CLIMBERHenley Intl.1994-05-05