Medical Device Manufacturer · US , Irvine , CA

American Imex - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1986

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Imex Neurology ✕

11 devices

1-11 of 11

Cleared Jan 07, 2004

Neurology · 194d

Cleared Sep 22, 1998

Neurology · 90d

Cleared Jun 01, 1993

Neurology · 169d

Cleared Nov 22, 1991

ULTIMA XS, MODIFICATION

Neurology · 183d

Cleared Nov 06, 1989

ULTIMA XS MICROCURRENT TENS

Neurology · 73d

Cleared Aug 10, 1989

Neurology · 24d

Cleared May 04, 1988

Neurology · 15d

Cleared Apr 11, 1988

PREMIER 10S (TENS)

Neurology · 6d

Cleared Apr 06, 1988

ULTIMA XS (TENS)

Neurology · 42d

Cleared Feb 20, 1987

A-TENS - MODEL AI-87

Neurology · 78d

Cleared May 16, 1986

A TENS (MODEL AI-86)

Neurology · 11d