Device Type ID | 5222 |
Device Name | Cushion, Flotation, Therapeutic |
Regulation Description | Powered Flotation Therapy Bed. |
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) Exempt |
CFR Regulation Number | 890.5170 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MOC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5222 |
Device | Cushion, Flotation, Therapeutic |
Product Code | MOC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Powered Flotation Therapy Bed. |
CFR Regulation Number | 890.5170 [🔎] |