Device |
orthosis, pneumatic structure, rigid |
Regulation Description |
Rigid pneumatic structure orthosis. |
Definition |
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96 |
Regulation Medical Specialty |
Physical Medicine |
Review Panel |
Physical Medicine |
Product Code | IPO |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
Submission Type |
PMA
|
Regulation Number |
890.3610
|
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 |
|
|