Medical Device Manufacturer · US , Bay Shore , NY

Lumex, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1990

Recent clearances: LUMEX AIR, AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lumex, Inc. Physical Medicine ✕

4 devices

1-4 of 4

Cleared May 12, 1995

MECHANICAL WHEELCHAIR 890.3850

Physical Medicine · 203d

Cleared Apr 26, 1995

577ES (ERGOSENSE)

Physical Medicine · 180d

Cleared Oct 17, 1994

LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)

Physical Medicine · 28d

Cleared Feb 12, 1993

Physical Medicine · 189d