Dynamometer, Nonpowered

Device Code: 3812

Product Code(s): HRW

Device Classification Information

Device Type ID3812
Device NameDynamometer, Nonpowered
Regulation DescriptionNonpowered 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 Number888.1250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHRW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3812
DeviceDynamometer, Nonpowered
Product CodeHRW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonpowered Dynamometer.
CFR Regulation Number888.1250 [🔎]
TPLC Last Update: 2019-04-02 20:37:21

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