Henley Intl.

Houston, TX, US

Henley Intl. appears in FDA device records in Houston, TX. FDA records list 44 510(k) clearances between 1986-05-30 and 1995-11-15, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 44
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 44 510(k) clearances for Henley Intl. between 1986 and 1995. The busiest year on record is 1987, with 8. The most recent is 1995, with 1.

Clearances by year, as a table

510(k) clearance decisions for Henley Intl., by decision year
Year	Clearances
1986	4
1987	8
1988	4
1989	6
1990	6
1991	4
1992	2
1993	4
1994	5
1995	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K943449	NEUROLOGICAL DIAGNOSTIC DEVICES	GXY	Substantially Equivalent	1995-11-15
K926279	UPPER BODY EXERCISER	ISD	Substantially Equivalent	1994-05-05
K926278	STAIR CLIMBER	ISD	Substantially Equivalent	1994-05-05
K926287	EXERCISE BICYCLE	ISD	Substantially Equivalent	1994-03-22
K926314	HYDRA FITNESS MODEL 311 TOTAL POWER	ISD	Substantially Equivalent	1994-03-18
K926313	COMPUTERIZED TESTING AND EXERCISE SYSTEMS	BXB	Substantially Equivalent	1994-02-04
K915864	MONOTRODE CUTANEOUS ELECTRODE	GXY	Substantially Equivalent	1993-07-21
K922036	SONOPULS 591	IMG	Substantially Equivalent	1993-06-29
K926316	TRUE-TRAC, STRATUS	JFB	Substantially Equivalent	1993-03-24
K920983	SONOPULS 590	IMI	Substantially Equivalent	1993-03-09
K922020	ENDOMED 582	LIH	Substantially Equivalent	1992-09-22
K921828	TEAM-MC II	GZJ	Substantially Equivalent	1992-09-22
K904377	ELECTROCONDUCTIVE MEDIA	GYB	Substantially Equivalent	1991-11-15
K905672	TEAM-MC	GZJ	Substantially Equivalent	1991-10-15
K903828	SYNAPS (TM)	GZJ	Substantially Equivalent	1991-01-18
K896817	MODEL T11 FLUIDOTHERAPY UNIT	LSB	Substantially Equivalent	1991-01-18
K900189	CURAPULS 403 DIATHERMY UNIT	IMG	Substantially Equivalent	1990-09-18
K901630	CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)	GYB	Substantially Equivalent	1990-07-16
K896620	NEUROTENS	GZJ	Substantially Equivalent	1990-04-26
K900419	CRYOTRON-UL30	IMF	Substantially Equivalent	1990-02-27
K895301	EMS 8100	IPF	Substantially Equivalent	1990-02-20
K894549	DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE	EGJ	Unknown	1990-02-09
K895334	TTS2600	GZJ	Substantially Equivalent	1989-10-30
K895211	TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	GZJ	Substantially Equivalent	1989-10-30
K895166	TTS2500	GZJ	Substantially Equivalent	1989-10-30
K895161	TTS2800	GZJ	Substantially Equivalent	1989-10-30
K884231	SURGICAL 'LASER' DRAPE	KKX	Substantially Equivalent	1989-04-20
K882643	AM TM SYRGICAL DRAPES	KKX	Substantially Equivalent for Some Indications	1989-03-03
K884348	MODIFIED JELTRODE(TM) ELECTRODES DEEMED	GXY	Substantially Equivalent	1988-12-15
K882169	SURGICAL DUCT CLAMP (VINE)	GDJ	Substantially Equivalent	1988-06-17
K880699	ENDOMED CV405	IPF	Substantially Equivalent	1988-05-02
K870384	ENDOMED 433	LIH	Substantially Equivalent	1988-04-13
K871802	MODEL K210 AND K211 FLUIDOTHERAPY UNITS	LSB	Substantially Equivalent	1987-09-04
K872394	SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT	IMG	Substantially Equivalent	1987-09-03
K872393	SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT	IMI	Substantially Equivalent	1987-07-23
K870515	DYNATRON 438	IPF	Substantially Equivalent	1987-06-16
K871107	VASOTRAIN 447	IRO	Substantially Equivalent for Some Indications	1987-05-29
K871112	PELTIERTHERAPY(C) HEAT/COLD TREATMENT	IMF	Substantially Equivalent	1987-05-06
K870667	OMEGA T200	GZJ	Substantially Equivalent	1987-04-22
K870666	OMEGA T100	GZJ	Substantially Equivalent	1987-04-22
K862855	CRAIG NASO-GASTRIC TUBE HOLDER	KNT	Substantially Equivalent	1986-11-04
K861956	JELTRODE	GXY	Substantially Equivalent	1986-06-26
K861248	CURAPULS 419 DIATHERMY UNIT	IMJ	Substantially Equivalent	1986-05-30
K861247	CURAMED 402 DIATHERMY UNIT	IMJ	Substantially Equivalent	1986-05-30

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain