Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ISA · Predicate Candidate Screening
100 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
380 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | 2025-02-06 | 86 | 0 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 | 120 | 0 |
| K221865 | BTL-094 | BTL Industries, Inc. | 2023-04-14 | 291 | 0 |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023-01-27 | 736 | 0 |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022-10-12 | 380 | 0 |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022-07-11 | 136 | 0 |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021-05-05 | 78 | 0 |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018-12-21 | 86 | 0 |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018-04-13 | 133 | 0 |
| K053225 | CELLU M6 KEYMODULE I | Lpg One, Inc. | 2006-11-06 | 354 | 0 |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | 2004-01-22 | 308 | 0 |
| K002908 | JET THERAPY | Jet Therapy | 2001-08-30 | 346 | 0 |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/ | Lpg USA, Inc. | 2000-01-18 | 342 | 0 |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | 1995-09-29 | 93 | 0 |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | 1995-08-14 | 105 | 0 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 | 183 | 0 |
| K950931 | AVON MASSAGING HAIRBRUSH | Siegel,Mandell & Davidson,P.C. | 1995-04-05 | 35 | 0 |
| K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Ultrassage, Inc. | 1995-03-07 | 34 | 0 |
| K950321 | SHAPE UP MOMI ROLLER | Kinsei Shiatsu, Inc. | 1995-02-14 | 19 | 0 |
| K944885 | DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM | Kolvin Industries , Ltd. | 1995-02-14 | 134 | 0 |
| K944730 | MASSAGER | North American Technical Services Corp. | 1995-02-14 | 141 | 0 |
| K950322 | RELAXY-THE WONDER HAND | Kinsei Shiatsu, Inc. | 1995-02-14 | 19 | 0 |
| K950320 | RELAXY-WONDER KNOCK | Kinsei Shiatsu, Inc. | 1995-02-14 | 19 | 0 |
| K944884 | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B | Kolvin Industries , Ltd. | 1995-02-14 | 134 | 0 |
| K936178 | AGILANCE-GOLDEN SPOONS | Oismuller & Partner Keg | 1995-01-18 | 387 | 0 |
| K944637 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-12-13 | 83 | 0 |
| K944024 | STIMU-TAP | Wahl Clipper Corp. | 1994-12-08 | 113 | 0 |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-09-29 | 93 | 0 |
| K942950 | BODY FLEX | Conair Corp. | 1994-07-26 | 33 | 0 |
| K940621 | PRO-SHIATSU PORTABLE MASSAGER | Westminster International Co., Inc. | 1994-06-22 | 128 | 0 |
| K942218 | SHIATSU MASSAGER | Westminster International Co., Inc. | 1994-06-22 | 47 | 0 |
| K942223 | BODY SYSTEM | Conair Corp. | 1994-06-09 | 34 | 0 |
| K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA | Wahl Clipper Corp. | 1994-06-09 | 119 | 0 |
| K941594 | WAHL DOUBLE COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | 69 | 0 |
| K940543 | MODEL 777 THERAPEUTIC MASSAGER | Voyager Medical Corp. | 1994-04-21 | 73 | 0 |
| K940369 | BODY RECHARGER | Conair Corp. | 1994-04-21 | 85 | 0 |
| K925907 | AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER | Pollenex Corp. | 1994-03-30 | 495 | 0 |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | 362 | 0 |
| K935462 | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 | Omron Healthcare, Inc. | 1994-03-04 | 112 | 0 |
| K926339 | BODY RELAXER | Conair Corp. | 1994-03-04 | 444 | 0 |
| K935581 | OMRON MASSAGER MODEL HM-102 | Omron Healthcare, Inc. | 1994-03-04 | 106 | 0 |
| K935459 | OMRON MASSAGER MODEL HM-45 | Omron Healthcare, Inc. | 1994-03-04 | 112 | 0 |
| K911727 | INFRADERM; TOUCH 'N TONE PLUS | Conair Corp. | 1994-02-25 | 1045 | 0 |
| K932904 | WINDMERE WAND MASSAGER | Windmere Corp. | 1994-02-17 | 246 | 0 |
| K924237 | WINDMERE PRELUDE III | Windmere Corp. | 1993-10-18 | 420 | 0 |
| K924518 | BODY SOOTHER | Conair Corp. | 1993-10-12 | 403 | 0 |
| K924520 | BODY TRAINER | Conair Corp. | 1993-09-30 | 391 | 0 |
| K925036 | HANDY VIBRO BELT | Cosmesearch, Inc. | 1993-06-29 | 267 | 0 |
| K923541 | BODY-MATE MASSAGER | American Therapy Products | 1993-06-24 | 343 | 0 |
| K921000 | SONACARE SOUND MASSAGER | Honor Trading, Ltd. | 1993-03-31 | 398 | 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