Company ยท US
Henley Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1995. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 |
| GXY | Electrode, Cutaneous | 4 |
| ISD | Exerciser, Measuring | 4 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 |
| IPF | Stimulator, Muscle, Powered | 3 |
| GYB | Media, Electroconductive | 2 |
| IMF | Unit, Chilling | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
| LIH | Interferential Current Therapy | 2 |
| LSB | Unit, Fluidotherapy | 2 |
| BXB | Exerciser, Powered | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 |
| IRO | Vibrator, Therapeutic | 1 |
| JFB | Table, Physical Therapy, Multi Function | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 1995 | K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES Henley Intl. | GXY |
| May 5, 1994 | K926279 | UPPER BODY EXERCISER Henley Intl. | ISD |
| May 5, 1994 | K926278 | STAIR CLIMBER Henley Intl. | ISD |
| Mar 22, 1994 | K926287 | EXERCISE BICYCLE Henley Intl. | ISD |
| Mar 18, 1994 | K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER Henley Intl. | ISD |
| Feb 4, 1994 | K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS Henley Intl. | BXB |
| Jul 21, 1993 | K915864 | MONOTRODE CUTANEOUS ELECTRODE Henley Intl. | GXY |
| Jun 29, 1993 | K922036 | SONOPULS 591 Henley Intl. | IMG |
| Mar 24, 1993 | K926316 | TRUE-TRAC, STRATUS Henley Intl. | JFB |
| Mar 9, 1993 | K920983 | SONOPULS 590 Henley Intl. | IMI |
| Sep 22, 1992 | K922020 | ENDOMED 582 Henley Intl. | LIH |
| Sep 22, 1992 | K921828 | TEAM-MC II Henley Intl. | GZJ |
| Nov 15, 1991 | K904377 | ELECTROCONDUCTIVE MEDIA Henley Intl. | GYB |
| Oct 15, 1991 | K905672 | TEAM-MC Henley Intl. | GZJ |
| Jan 18, 1991 | K903828 | SYNAPS (TM) Henley Intl. | GZJ |
| Jan 18, 1991 | K896817 | MODEL T11 FLUIDOTHERAPY UNIT Henley Intl. | LSB |
| Sep 18, 1990 | K900189 | CURAPULS 403 DIATHERMY UNIT Henley Intl. | IMG |
| Jul 16, 1990 | K901630 | CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275) Henley Intl. | GYB |
| Apr 26, 1990 | K896620 | NEUROTENS Henley Intl. | GZJ |
| Feb 27, 1990 | K900419 | CRYOTRON-UL30 Henley Intl. | IMF |
| Feb 20, 1990 | K895301 | EMS 8100 Henley Intl. | IPF |
| Feb 9, 1990 | K894549 | DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE Henley Intl. | EGJ |
| Oct 30, 1989 | K895334 | TTS2600 Henley Intl. | GZJ |
| Oct 30, 1989 | K895211 | TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Henley Intl. | GZJ |
| Oct 30, 1989 | K895166 | TTS2500 Henley Intl. | GZJ |
| Oct 30, 1989 | K895161 | TTS2800 Henley Intl. | GZJ |
| Apr 20, 1989 | K884231 | SURGICAL 'LASER' DRAPE Henley Intl. | KKX |
| Mar 3, 1989 | K882643 | AM TM SYRGICAL DRAPES Henley Intl. | KKX |
| Dec 15, 1988 | K884348 | MODIFIED JELTRODE(TM) ELECTRODES DEEMED Henley Intl. | GXY |
| Jun 17, 1988 | K882169 | SURGICAL DUCT CLAMP (VINE) Henley Intl. | GDJ |
| May 2, 1988 | K880699 | ENDOMED CV405 Henley Intl. | IPF |
| Apr 13, 1988 | K870384 | ENDOMED 433 Henley Intl. | LIH |
| Sep 4, 1987 | K871802 | MODEL K210 AND K211 FLUIDOTHERAPY UNITS Henley Intl. | LSB |
| Sep 3, 1987 | K872394 | SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT Henley Intl. | IMG |
| Jul 23, 1987 | K872393 | SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT Henley Intl. | IMI |
| Jun 16, 1987 | K870515 | DYNATRON 438 Henley Intl. | IPF |
| May 29, 1987 | K871107 | VASOTRAIN 447 Henley Intl. | IRO |
| May 6, 1987 | K871112 | PELTIERTHERAPY(C) HEAT/COLD TREATMENT Henley Intl. | IMF |
| Apr 22, 1987 | K870667 | OMEGA T200 Henley Intl. | GZJ |
| Apr 22, 1987 | K870666 | OMEGA T100 Henley Intl. | GZJ |
| Nov 4, 1986 | K862855 | CRAIG NASO-GASTRIC TUBE HOLDER Henley Intl. | KNT |
| Jun 26, 1986 | K861956 | JELTRODE Henley Intl. | GXY |
| May 30, 1986 | K861248 | CURAPULS 419 DIATHERMY UNIT Henley Intl. | IMJ |
| May 30, 1986 | K861247 | CURAMED 402 DIATHERMY UNIT Henley Intl. | IMJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||