Device Type ID | 5196 |
Device Name | Table, Physical Therapy, Multi Function |
Regulation Description | Multi-function Physical Therapy Table. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Physical Medicine |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | 510(k) |
CFR Regulation Number | 890.5880 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | JFB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 5196 |
Device | Table, Physical Therapy, Multi Function |
Product Code | JFB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Multi-function Physical Therapy Table. |
CFR Regulation Number | 890.5880 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
CERAGEM INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUGA MEDICAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 |