| Device |
peripheral electromagnetic field (pemf) to aid wound healing |
| Review Panel |
Physical Medicine |
| Product Code | MBQ |
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
Contact ODE
|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
| Implanted Device? |
No
|
| Life-Sustain/Support Device? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|