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510(k) K790528

Device
THERAPY GYROSCOPE
Applicant
MADDAK, INC.
510(k) number
K790528
Product code
KNL  
Decision
Substantially Equivalent (SESE)
Decision date
1979-04-03
Date received
1979-03-15
Regulation
890.5370
Classification name
Board, Scooter, Prone
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K841695CRAWLERMaddak, Inc.1984-05-10
K811489SCOOTER BOARDFred Sammons, Inc.1981-06-12
K781198BOARD, SCOOTERFred Sammons, Inc.1978-07-31
K780296THERAPY SCOOTERConvaid Product Development1978-02-24

Legacy Summary#

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FDA Review#

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