Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Rich-Mar Corp. — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

68 daysmedian FDA review time

174 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K040679	RICH-MAR AUTOPRISM INFRARED LAMP	Rich-Mar Corp.	2004-05-07	53
K031018	AUTOGEL PAD	Rich-Mar Corp.	2003-12-08	252
K032941	AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUN	Rich-Mar Corp.	2003-10-22	30
K021483	RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND	Rich-Mar Corp.	2002-09-13	128
K013770	MODIFICATION TO: WINNER ST-2 STIMULATOR	Rich-Mar Corp.	2002-01-18	66
K013771	MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAP	Rich-Mar Corp.	2002-01-18	66
K012848	WINNER CM4 COMBINATION UNIT	Rich-Mar Corp.	2001-10-25	63
K000808	RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND T	Rich-Mar Corp.	2000-08-25	165
K982544	RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICE	Rich-Mar Corp.	1998-11-19	121
K952089	RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, T	Rich-Mar Corp.	1995-08-11	100
K950564	RICH-MAR US-II ULTRASOUND	Rich-Mar Corp.	1995-05-15	96
K950491	RICH-MAR CARBON ELECTRODES	Rich-Mar Corp.	1995-03-29	51
K932868	THERATOUCH 4.7	Rich-Mar Corp.	1994-07-29	410
K923797	MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED	Rich-Mar Corp.	1992-11-06	101
K920833	RICH-MAR HV 1000 MUSCLE STIMULATOR	Rich-Mar Corp.	1992-05-22	87
K915557	RICH-MAR MODEL 510 ULTRASOUND	Rich-Mar Corp.	1992-03-10	90
K914539	RICH-MAR IFV 1000	Rich-Mar Corp.	1991-12-18	68
K913981	RICH-MAR MODEL II ULTRASOUND	Rich-Mar Corp.	1991-11-13	68
K912202	RICH-MAR MODEL 25 ULTRASOUND	Rich-Mar Corp.	1991-09-17	120
K910708	RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE	Rich-Mar Corp.	1991-05-21	90
K904051	RICH-MAR MODEL V ULTRASOUND	Rich-Mar Corp.	1991-01-14	132
K901779	RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT	Rich-Mar Corp.	1990-06-26	70
K893994	IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT	Rich-Mar Corp.	1989-12-14	192
K890147	RICH-MAR CONDUCTIVE GEL II W/ALOE VERA	Rich-Mar Corp.	1989-03-23	69
K883659	HLE-1000 HIGH/LOW TREATMENT TABLE	Rich-Mar Corp.	1988-10-13	48
K880948	RICH-MAR G1000 EMS	Rich-Mar Corp.	1988-04-21	45
K874736	RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR	Rich-Mar Corp.	1988-01-22	65
K872036	RICH-MAR CONDUCTIVE GEL	Rich-Mar Corp.	1987-11-17	174
K864653	MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS	Rich-Mar Corp.	1986-12-29	31
K862469	RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC	Rich-Mar Corp.	1986-07-10	10
K862468	RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC	Rich-Mar Corp.	1986-07-10	10
K861832	RICH-MAR SPINA-MOBILIZOR	Rich-Mar Corp.	1986-06-27	45
K854485	RICH-MAR IF 200	Rich-Mar Corp.	1986-06-10	215
K844466	THE PROBE 100	Rich-Mar Corp.	1985-02-21	94
K844036	US 610	Rich-Mar Corp.	1984-11-27	42
K844217	RICH-MAR DELTA 330 HV	Rich-Mar Corp.	1984-11-27	27
K830055	RICH-MAR HV 20	Rich-Mar Corp.	1983-03-10	57
K810526	RICH-MAR HV II SELECT-A-PULSE	Rich-Mar Corp.	1981-04-03	36
K781113	MUSCLE STIMULATOR, ELECTRICAL	Rich-Mar Corp.	1978-09-26	85
K781167	STEMPLEX	Rich-Mar Corp.	1978-09-15	64
K772287	MUSCLE STIMULATOR	Rich-Mar Corp.	1978-01-13	32
K771157	RM VI-HV	Rich-Mar Corp.	1977-07-21	23
K761053	ANODYNE II-ELECTRICAL NEURO STIMULATOR	Rich-Mar Corp.	1976-11-30	15

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda