IPL · Class II · 21 CFR 890.3900

FDA Product Code IPL: Wheelchair, Standup

Leading manufacturers include Permobil AB, Action Manufacturing, Inc. and Powerbasetec GmbH.

66
Total
66
Cleared
134d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 93d recently vs 134d historically

FDA 510(k) Cleared Wheelchair, Standup Devices (Product Code IPL)

66 devices
1–24 of 66

About Product Code IPL - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code IPL since 1979, with 66 receiving FDA clearance (average review time: 134 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under IPL have taken an average of 93 days to reach a decision - down from 134 days historically, suggesting improved FDA processing for this classification.

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