Device Type ID | 5147 |
Device Name | Belt, Wheelchair |
Regulation Description | Wheelchair Component. |
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 | 890.3920 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | IQB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5147 |
Device | Belt, Wheelchair |
Product Code | IQB |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Wheelchair Component. |
CFR Regulation Number | 890.3920 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 1 |