Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
IRO — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
397 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955160 | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED | Everapex Design & Marketing Corp. | 1996-02-08 | 87 | 0 |
| K955250 | QI GONG MASSAGER | East Health Development Group, Inc. | 1996-02-08 | 87 | 0 |
| K954203 | MASSAGER THERAPUTIC, ELECTRIC | Cisco Sales Corp. | 1995-12-11 | 95 | 0 |
| K952916 | SHIATSU MASTER MASSAGER CUSHION | Kinsei Shiatsu, Inc. | 1995-08-28 | 63 | 0 |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | Champion Mfg. Corp. | 1995-08-11 | 137 | 0 |
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Conair Corp. | 1995-07-18 | 172 | 0 |
| K946382 | SKALPI 3200 | Wiscco Development, Inc. | 1995-05-30 | 167 | 0 |
| K950410 | CONAIR BODY AND SOLE | Conair Corp. | 1995-05-23 | 112 | 0 |
| K944909 | WAHL FRESH FACE | Wahl Clipper Corp. | 1995-05-08 | 215 | 0 |
| K950400 | HAND MASSAGE UNIT | Ultrassage, Inc. | 1995-03-30 | 57 | 0 |
| K945603 | CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) | Headwaters, Inc. | 1995-02-09 | 86 | 0 |
| K940582 | MASSAGING HELMET C.F. HANSEN DESIGN | Philco Ushuaia | 1995-01-30 | 356 | 0 |
| K943730 | SQUEEZE PLAY | Conair Corp. | 1994-11-28 | 118 | 0 |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | 78 | 0 |
| K934886 | NEXT WAVE PHYSIOACOUSTIC MATTRESS | Next Wave, Inc. | 1994-06-09 | 240 | 0 |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | 106 | 0 |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | 362 | 0 |
| K931638 | FO96 HANDY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | 362 | 0 |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Fairform Mfg., Co., Ltd. | 1994-03-28 | 363 | 0 |
| K931640 | AO11 BODY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | 362 | 0 |
| K923238 | SONASSAGE | Conair Corp. | 1994-02-02 | 580 | 0 |
| K933974 | WINDMERE MASSAGE MATE | Windmere Corp. | 1994-02-02 | 173 | 0 |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Carapace, Inc. | 1994-01-26 | 293 | 0 |
| K924581 | HEALTH ESSENTIALS MAXI MASSAGER | Conair Corp. | 1993-10-12 | 397 | 0 |
| K924582 | HEALTH ESSENTIALS BODY CARE MASSAGER | Conair Corp. | 1993-10-12 | 397 | 0 |
| K924584 | HEALTH ESSENTIALS FANCY PERSONAL MASSAGER | Conair Corp. | 1993-10-12 | 397 | 0 |
| K924519 | BODYTHERM | Conair Corp. | 1993-10-12 | 403 | 0 |
| K924583 | HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER | Conair Corp. | 1993-10-12 | 397 | 0 |
| K924431 | HEALTLH ESSENTIALS PERSONAL MASSAGER | Conair Corp. | 1993-10-12 | 406 | 0 |
| K931086 | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER | Windmere Corp. | 1993-09-30 | 211 | 0 |
| K920487 | MINI VIBRATOR | Alimed, Inc. | 1992-02-18 | 19 | 0 |
| K913439 | SONIX...THERAPEUTIC SONIC MASSAGE | Mcshirley Products, Inc. | 1992-01-22 | 173 | 0 |
| K913998 | PAM PLUS | Kinetic Concepts, Inc. | 1992-01-08 | 124 | 0 |
| K915242 | TOUCH N TONE 1 MASSAGER | Conair Corp. | 1991-12-20 | 37 | 0 |
| K914707 | F055 B.O. FANTASTIC RELAXER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 52 | 0 |
| K914703 | F383 RECHARGEABLE MINI MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 52 | 0 |
| K914830 | A101 LITESSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 45 | 0 |
| K914829 | FO92 SEATING MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 45 | 0 |
| K914704 | FO69 FANCY MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 52 | 0 |
| K914706 | FO51/F151 GOLF MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 52 | 0 |
| K914705 | FO41 BODY MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | 52 | 0 |
| K914344 | MULTI-REACH II WAND MASSAGER | Conair Corp. | 1991-10-24 | 27 | 0 |
| K912659 | SOUND RELIEF | Windmere Corp. | 1991-09-06 | 81 | 0 |
| K912479 | MOTOR MASSAGE PILLOW | Supreme Import , Ltd. | 1991-08-09 | 67 | 0 |
| K905836 | ULTRA WAVE 101 | Ako USA, Inc. | 1991-01-14 | 14 | 0 |
| K903098 | MINI-VIBRATOR | Frank J. Biehl | 1990-07-25 | 12 | 0 |
| K901931 | LEG EEZE | Jereva, Inc. | 1990-06-14 | 45 | 0 |
| K896947 | CHIROPRACTIC MASSAGE PILLOW | Intl. Pacific Industrial Corp. (Usa), Inc. | 1990-01-02 | 20 | 0 |
| K883913 | LA MASSEUSE | Sobel Shipping Co., Inc. | 1988-11-16 | 61 | 0 |
| K871107 | VASOTRAIN 447 | Henley Intl. | 1987-05-29 | 71 | 0 |
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