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

Fairform Mfg., Co., Ltd. — Predicate Candidate Screening

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

52 daysmedian FDA review time

362 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K931637	A013 FEMI-FORM FACIAL MASSAGER	Fairform Mfg., Co., Ltd.	1994-03-28	362
K931638	FO96 HANDY MASSAGER	Fairform Mfg., Co., Ltd.	1994-03-28	362
K931636	FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER	Fairform Mfg., Co., Ltd.	1994-03-28	362
K931639	F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR	Fairform Mfg., Co., Ltd.	1994-03-28	363
K931640	AO11 BODY MASSAGER	Fairform Mfg., Co., Ltd.	1994-03-28	362
K920644	F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND	Fairform Mfg., Co., Ltd.	1992-05-29	107
K914707	F055 B.O. FANTASTIC RELAXER	Fairform Mfg., Co., Ltd.	1991-12-09	52
K914703	F383 RECHARGEABLE MINI MASSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	52
K914830	A101 LITESSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	45
K914829	FO92 SEATING MASSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	45
K914704	FO69 FANCY MASSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	52
K914706	FO51/F151 GOLF MASSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	52
K914705	FO41 BODY MASSAGER	Fairform Mfg., Co., Ltd.	1991-12-09	52

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