Medical Device Manufacturer · US , Houston , TX

Henley Intl.

44 submissions · 41 cleared · Since 1986
44
Total
41
Cleared
0
Denied

Henley Intl. — FDA 510(k) Submissions

Henley Intl. has submitted 44 FDA 510(k) premarket notifications since 1986, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Transcutaneous, For Pain Relief, Exerciser, Measuring, Electrode, Cutaneous, Stimulator, Muscle, Powered, Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · GXY Electrode, Cutaneous · Neurology
Nov 1995 485d
STAIR CLIMBER
K926278 · ISD Exerciser, Measuring · Physical Medicine
May 1994 507d
UPPER BODY EXERCISER
K926279 · ISD Exerciser, Measuring · Physical Medicine
May 1994 507d
EXERCISE BICYCLE
K926287 · ISD Exerciser, Measuring · Physical Medicine
Mar 1994 463d
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314 · ISD Exerciser, Measuring · Physical Medicine
Mar 1994 458d
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K926313 · BXB Exerciser, Powered · Physical Medicine
Feb 1994 416d
MONOTRODE CUTANEOUS ELECTRODE
K915864 · GXY Electrode, Cutaneous · Neurology
Jul 1993 568d
SONOPULS 591
K922036 · IMG Stimulator, Ultrasound... · Physical Medicine
Jun 1993 424d
TRUE-TRAC, STRATUS
K926316 · JFB Table, Physical Therapy,... · Physical Medicine
Mar 1993 99d
SONOPULS 590
K920983 · IMI Ultrasonic Diathermy For... · Physical Medicine
Mar 1993 372d
TEAM-MC II
K921828 · GZJ Stimulator, Nerve,... · Neurology
Sep 1992 159d
ENDOMED 582
K922020 · LIH Interferential Current... · Neurology
Sep 1992 145d
ELECTROCONDUCTIVE MEDIA
K904377 · GYB Media, Electroconductive · Neurology
Nov 1991 417d
TEAM-MC
K905672 · GZJ Stimulator, Nerve,... · Neurology
Oct 1991 301d
MODEL T11 FLUIDOTHERAPY UNIT
K896817 · LSB Unit, Fluidotherapy · Physical Medicine
Jan 1991 410d
SYNAPS (TM)
K903828 · GZJ Stimulator, Nerve,... · Neurology
Jan 1991 150d
CURAPULS 403 DIATHERMY UNIT
K900189 · IMG Stimulator, Ultrasound... · Physical Medicine
Sep 1990 245d
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · GYB Media, Electroconductive · Neurology
Jul 1990 98d
NEUROTENS
K896620 · GZJ Stimulator, Nerve,... · Neurology
Apr 1990 156d
CRYOTRON-UL30
K900419 · IMF Unit, Chilling · Physical Medicine
Feb 1990 28d
EMS 8100
K895301 · IPF Stimulator, Muscle, Powered · Physical Medicine
Feb 1990 179d
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · EGJ Device, Iontophoresis,... · Physical Medicine
Feb 1990 204d
TTS2800
K895161 · GZJ Stimulator, Nerve,... · Neurology
Oct 1989 69d
TTS2500
K895166 · GZJ Stimulator, Nerve,... · Neurology
Oct 1989 69d
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · GZJ Stimulator, Nerve,... · Neurology
Oct 1989 73d
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