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

LYG — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

115 daysmedian FDA review time

522 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K963704	MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE	Shippert Medical Technologies Corp.	1996-11-26	71
K936312	MANUAL MASSAGE ROLLER	Mckenna & Cuneo	1996-01-29	794
K952043	BACK MASSAGER	Eight Corners, Inc.	1995-09-01	123
K930613	HOOKING SYSTEM	Alain Machtelinckx	1994-07-12	522
K936148	STRESS HANDLER	Arocep Enterprises , Ltd.	1994-04-21	115
K924315	THE MASSAGER	Four Directions	1993-10-08	408
K922366	SPINE LINE	Dambrecine, Inc.	1992-07-13	54
K915361	THE BODY BUGGY	Innova Corp.	1991-12-20	23
K912512	TAICHI STICK MASSAGER	Focus International, Inc.	1991-09-06	92
K903820	THERA-CANE	Pro Message Co.	1990-09-19	30
K884907	BUMPY MEDICAL MASSAGE MAT	Medical Flotation Systems, Inc.	1988-12-27	34
K881081	DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER	Ferguson Medical	1988-07-21	129
K881080	DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER	Ferguson Medical	1988-07-21	129

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