Device |
manipulator, plunger-like joint |
Review Panel |
Physical Medicine |
Product Code | LXM |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Unclassified Reason
|
Pre-Amendment
|
Submission Type |
510(k)
|
Device Class |
Unclassified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|