Medical Device Manufacturer · US , Houston , TX

Henley Intl. - FDA 510(k) Cleared Devices

44 submissions · 41 cleared · Since 1986

44

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - Henley Intl. Physical Medicine ✕

22 devices

1-12 of 22

Cleared May 05, 1994

Physical Medicine · 507d

Cleared May 05, 1994

UPPER BODY EXERCISER

Physical Medicine · 507d

Cleared Mar 22, 1994

EXERCISE BICYCLE

Physical Medicine · 463d

Cleared Mar 18, 1994

HYDRA FITNESS MODEL 311 TOTAL POWER

Physical Medicine · 458d

Cleared Feb 04, 1994

COMPUTERIZED TESTING AND EXERCISE SYSTEMS

Physical Medicine · 416d

Cleared Jun 29, 1993

Physical Medicine · 424d

Cleared Mar 24, 1993

TRUE-TRAC, STRATUS

Physical Medicine · 99d

Cleared Mar 09, 1993

Physical Medicine · 372d

Cleared Jan 18, 1991

MODEL T11 FLUIDOTHERAPY UNIT

Physical Medicine · 410d

Cleared Sep 18, 1990

CURAPULS 403 DIATHERMY UNIT

Physical Medicine · 245d

Cleared Feb 27, 1990

Physical Medicine · 28d

Cleared Feb 20, 1990

Physical Medicine · 179d