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
1-22 of 22
Cleared May 05, 1994
STAIR CLIMBER
K926278 · ISD
Physical Medicine · 507d
Cleared May 05, 1994
UPPER BODY EXERCISER
K926279 · ISD
Physical Medicine · 507d
Cleared Mar 22, 1994
EXERCISE BICYCLE
K926287 · ISD
Physical Medicine · 463d
Cleared Mar 18, 1994
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314 · ISD
Physical Medicine · 458d
Cleared Feb 04, 1994
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K926313 · BXB
Physical Medicine · 416d
Cleared Jun 29, 1993
SONOPULS 591
K922036 · IMG
Physical Medicine · 424d
Cleared Mar 24, 1993
TRUE-TRAC, STRATUS
K926316 · JFB
Physical Medicine · 99d
Cleared Mar 09, 1993
SONOPULS 590
K920983 · IMI
Physical Medicine · 372d
Cleared Jan 18, 1991
MODEL T11 FLUIDOTHERAPY UNIT
K896817 · LSB
Physical Medicine · 410d
Cleared Sep 18, 1990
CURAPULS 403 DIATHERMY UNIT
K900189 · IMG
Physical Medicine · 245d
Cleared Feb 27, 1990
CRYOTRON-UL30
K900419 · IMF
Physical Medicine · 28d
Cleared Feb 20, 1990
EMS 8100
K895301 · IPF
Physical Medicine · 179d
Cleared Feb 09, 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · EGJ
Physical Medicine · 204d
Cleared May 02, 1988
ENDOMED CV405
K880699 · IPF
Physical Medicine · 70d
Cleared Sep 04, 1987
MODEL K210 AND K211 FLUIDOTHERAPY UNITS
K871802 · LSB
Physical Medicine · 119d
Cleared Sep 03, 1987
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · IMG
Physical Medicine · 83d
Cleared Jul 23, 1987
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · IMI
Physical Medicine · 41d
Cleared Jun 16, 1987
DYNATRON 438
K870515 · IPF
Physical Medicine · 131d
Cleared May 29, 1987
VASOTRAIN 447
K871107 · IRO
Physical Medicine · 71d
Cleared May 06, 1987
PELTIERTHERAPY(C) HEAT/COLD TREATMENT
K871112 · IMF
Physical Medicine · 48d
Cleared May 30, 1986
CURAMED 402 DIATHERMY UNIT
K861247 · IMJ
Physical Medicine · 58d
Cleared May 30, 1986
CURAPULS 419 DIATHERMY UNIT
K861248 · IMJ
Physical Medicine · 58d
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