| Device Type ID | 5186 |
| Device Name | Equipment, Traction, Powered |
| Regulation Description | Power Traction Equipment. |
| 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 | 890.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ITH |
| 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 | 5186 |
| Device | Equipment, Traction, Powered |
| Product Code | ITH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Power Traction Equipment. |
| CFR Regulation Number | 890.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHAMPFIVE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENRAF-NONIUS B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRITY LIFE SCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEW COMPANY INVESTMENTS B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIVOTAL HEALTH SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Mechanical Problem | 2 |
Device Operates Differently Than Expected | 2 |
Device Operational Issue | 1 |
Unintended System Motion | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Collapse | 1 |
Protective Measures Problem | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Advanced Back Technologies, Inc. | II | Jun-05-2015 |