JFB · Class II · 21 CFR 890.5880

FDA Product Code JFB: Table, Physical Therapy, Multi Function

Leading manufacturers include Ceragem Co., Ltd., Nuga Medical Co., Ltd. and Marzzan Lucas Jorge.

66
Total
66
Cleared
122d
Avg days
1982
Since
Growing category - 5 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 149d recently vs 119d historically

FDA 510(k) Cleared Table, Physical Therapy, Multi Function Devices (Product Code JFB)

66 devices
1–24 of 66

About Product Code JFB - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code JFB since 1982, with 66 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under JFB have taken an average of 149 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

JFB devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →