Goniometer, Ac-powered

Device Code: 3815

Product Code(s): KQX

Device Classification Information

Device Type ID3815
Device NameGoniometer, Ac-powered
Regulation DescriptionGoniometer.
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 Number888.1500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKQX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3815
DeviceGoniometer, Ac-powered
Product CodeKQX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGoniometer.
CFR Regulation Number888.1500 [🔎]
TPLC Last Update: 2019-04-02 20:37:25

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