Table, Physical Therapy, Multi Function

Device Code: 5196

Product Code(s): JFB

Device Classification Information

Device Type ID5196
Device NameTable, Physical Therapy, Multi Function
Regulation DescriptionMulti-function Physical Therapy Table.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
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)
CFR Regulation Number890.5880 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJFB
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 ID5196
DeviceTable, Physical Therapy, Multi Function
Product CodeJFB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMulti-function Physical Therapy Table.
CFR Regulation Number890.5880 [🔎]
Premarket Reviews
ManufacturerDecision
CERAGEM INTERNATIONAL, INC.
 
SUBSTANTIALLY EQUIVALENT
1
NUGA MEDICAL CO., LTD
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 21:01:59

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