ILX · Class II · 21 CFR 890.5290

FDA Product Code ILX: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Leading manufacturers include Caerus Corporation.

15
Total
15
Cleared
200d
Avg days
1989
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 216d avg (recent)

FDA 510(k) Cleared Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat Devices (Product Code ILX)

15 devices
1–15 of 15
Cleared Dec 18, 2024
Active System
K241395
Caerus Corporation
Physical Medicine · 216d

About Product Code ILX - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code ILX since 1989, with 15 receiving FDA clearance (average review time: 200 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

FDA review times for ILX submissions have been consistent, averaging 216 days recently vs 199 days historically.

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