Dynamometer, Ac-powered

Device Code: 3816

Product Code(s): LBB

Device Classification Information

Device Type ID3816
Device NameDynamometer, Ac-powered
Regulation DescriptionAC-powered Dynamometer.
Regulation Medical SpecialtyOrthopedic
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number888.1240 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLBB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3816
DeviceDynamometer, Ac-powered
Product CodeLBB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAC-powered Dynamometer.
CFR Regulation Number888.1240 [🔎]
TPLC Last Update: 2019-04-02 20:37:26

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