FDA.reportPublic FDA data

510(k) K811489

Device
Scooter Board
Applicant
FRED SAMMONS, INC.
510(k) number
K811489
Product code
KNL
Decision
Substantially Equivalent (SESE)
Decision date
1981-06-12
Date received
1981-05-26
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
K790528THERAPY GYROSCOPEMaddak, Inc.1979-04-03
K781198BOARD, SCOOTERFred Sammons, Inc.1978-07-31
K780296THERAPY SCOOTERConvaid Product Development1978-02-24