Device Type ID | 5086 |
Device Name | Cabinet, Moist Steam |
Regulation Description | Moist Steam Cabinet. |
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 | 890.5250 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | IMB |
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 | 5086 |
Device | Cabinet, Moist Steam |
Product Code | IMB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Moist Steam Cabinet. |
CFR Regulation Number | 890.5250 [🔎] |