Device Type ID | 4472 |
Device Name | Belt, Pelvic, Traction |
Regulation Description | Noninvasive Traction Component. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 888.5890 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HSQ |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4472 |
Device | Belt, Pelvic, Traction |
Product Code | HSQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Noninvasive Traction Component. |
CFR Regulation Number | 888.5890 [🔎] |