Device |
stimulator, muscle, powered |
Regulation Description |
Powered muscle stimulator. |
Regulation Medical Specialty |
Physical Medicine |
Review Panel |
Physical Medicine |
Product Code | IPF |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
890.5850
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|