Henley Intl.
Medical device manufacturer in Sugar Land, TX.
44510(k) clearances
0PMA approvals
0recalls
Device types
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 10
- GXY Electrode, Cutaneous 4
- ISD Exerciser, Measuring 4
- IPF Stimulator, Muscle, Powered 3
- IMG Stimulator, Ultrasound And Muscle, For Use… 3
- IMF Unit, Chilling 2
- IMI Ultrasonic Diathermy For Use In Applying… 2
- LSB Unit, Fluidotherapy 2
- LIH Interferential Current Therapy 2
- KKX Drape, Surgical, Antimicrobial 2
- GYB Media, Electroconductive 2
- IMJ Diathermy, Shortwave, For Use In Applying… 2
- KNT Tubes, Gastrointestinal (And Accessories) 1
- IRO Vibrator, Therapeutic 1
- GDJ Clamp, Surgical, General & Plastic Surgery 1
- EGJ Device, Iontophoresis, Other Uses 1
- JFB Table, Physical Therapy, Multi Function 1
- BXB Exerciser, Powered 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K943449 | Neurological Diagnostic DevicesGXY · Traditional | 11/15/1995SE |
| K926279 | Upper Body ExerciserISD · Traditional | 05/05/1994SE |
| K926278 | Stair ClimberISD · Traditional | 05/05/1994SE |
| K926287 | Exercise BicycleISD · Traditional | 03/22/1994SE |
| K926314 | Hydra Fitness Model 311 Total PowerISD · Traditional | 03/18/1994SE |
| K926313 | Computerized Testing and Exercise SystemsBXB · Traditional | 02/04/1994SE |
| K915864 | Monotrode Cutaneous ElectrodeGXY · Traditional | 07/21/1993SE |
| K922036 | Sonopuls 591IMG · Traditional | 06/29/1993SE |
| K926316 | True-Trac, StratusJFB · Traditional | 03/24/1993SE |
| K920983 | Sonopuls 590IMI · Traditional | 03/09/1993SE |
| K922020 | Endomed 582LIH · Traditional | 09/22/1992SE |
| K921828 | Team-Mc IIGZJ · Traditional | 09/22/1992SE |
| K904377 | Electroconductive MediaGYB · Traditional | 11/15/1991SE |
| K905672 | Team-McGZJ · Traditional | 10/15/1991SE |
| K903828 | Synaps (TM)GZJ · Traditional | 01/18/1991SE |
| K896817 | Model T11 Fluidotherapy UnitLSB · Traditional | 01/18/1991SE |
| K900189 | Curapuls 403 Diathermy UnitIMG · Traditional | 09/18/1990SE |
| K901630 | Chempad(Tm), Electroconductive Media (882.1275)GYB · Traditional | 07/16/1990SE |
| K896620 | NeurotensGZJ · Traditional | 04/26/1990SE |
| K900419 | CRYOTRON-UL30IMF · Traditional | 02/27/1990SE |
| K895301 | EMS 8100IPF · Traditional | 02/20/1990SE |
| K894549 | Dynaphor(Tm) 101, Iontophoresis DeviceEGJ · Traditional | 02/09/1990SESD |
| K895334 | TTS2600GZJ · Traditional | 10/30/1989SE |
| K895211 | TTS2700 Transcutaneous Electrical Nerve StimulatorGZJ · Traditional | 10/30/1989SE |
| K895166 | TTS2500GZJ · Traditional | 10/30/1989SE |
| K895161 | TTS2800GZJ · Traditional | 10/30/1989SE |
| K884231 | Surgical 'Laser' DrapeKKX · Traditional | 04/20/1989SE |
| K882643 | Am TM Syrgical DrapesKKX · Traditional | 03/03/1989SN |
| K884348 | Modified Jeltrode(Tm) Electrodes DeemedGXY · Traditional | 12/15/1988SE |
| K882169 | Surgical Duct Clamp (Vine)GDJ · Traditional | 06/17/1988SE |
| K880699 | Endomed CV405IPF · Traditional | 05/02/1988SE |
| K870384 | Endomed 433LIH · Traditional | 04/13/1988SE |
| K871802 | Model K210 and K211 Fluidotherapy UnitsLSB · Traditional | 09/04/1987SE |
| K872394 | Sonopuls 464, Ultrasound Therapy EquipmentIMG · Traditional | 09/03/1987SE |
| K872393 | Sonopuls 463, Ultrasound Therapy EquipmentIMI · Traditional | 07/23/1987SE |
| K870515 | Dynatron 438IPF · Traditional | 06/16/1987SE |
| K871107 | Vasotrain 447IRO · Traditional | 05/29/1987SN |
| K871112 | Peltiertherapy(C) Heat/Cold TreatmentIMF · Traditional | 05/06/1987SE |
| K870667 | Omega T200GZJ · Traditional | 04/22/1987SE |
| K870666 | Omega T100GZJ · Traditional | 04/22/1987SE |
| K862855 | Craig Naso-Gastric Tube HolderKNT · Traditional | 11/04/1986SE |
| K861956 | JeltrodeGXY · Traditional | 06/26/1986SE |
| K861248 | Curapuls 419 Diathermy UnitIMJ · Traditional | 05/30/1986SE |
| K861247 | Curamed 402 Diathermy UnitIMJ · Traditional | 05/30/1986SE |