Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFB · Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
279 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. | 2025-07-11 | 162 | 0 |
| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, | Marzzan Lucas Jorge | 2025-01-31 | 277 | 0 |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-230 | Ceragem Co., Ltd. | 2025-01-08 | 43 | 0 |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. | 2024-11-27 | 29 | 0 |
| K240168 | N7-S | Nuga Medical Co., Ltd. | 2024-09-12 | 234 | 0 |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM | Ceragem Co., Ltd. | 2022-06-17 | 109 | 0 |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-M | Ceragem Co., Ltd. | 2021-03-18 | 169 | 0 |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | Ceragem Co., Ltd. | 2021-03-02 | 215 | 0 |
| K153054 | N5-1 | Nuga Medical Co., Ltd. | 2016-02-05 | 108 | 0 |
| K140592 | CERAGEM AUTOMATIC THERMAL MASSAGER | Ceragem International, Inc. | 2014-12-17 | 285 | 0 |
| K111588 | LEGACY-500 | Mt Tables, LLC | 2012-10-26 | 507 | 0 |
| K111941 | CHOYANG THERMAL MASSAGER | Choyang Medical Instrument Co., Ltd. | 2012-05-25 | 322 | 0 |
| K102938 | ACQPOINT THERMAJADE MASSAGE TABLE | Acqpoint, Inc. | 2011-09-23 | 354 | 0 |
| K111329 | NM-7000 | Nuga Medical Co., Ltd. | 2011-09-06 | 118 | 0 |
| K102281 | THERMAL MASSAGE BED, MODEL 2D-GX | Inarex Corporation | 2010-12-22 | 133 | 0 |
| K092731 | VIBRO-TRAC | Pneumex, Inc. | 2010-06-10 | 279 | 0 |
| K080554 | INAREX, MODEL 2D-LX | Inarex Corporation | 2008-08-27 | 181 | 0 |
| K070672 | MASSAGE MATTRESS VM9100RM | Metek GmbH | 2007-06-26 | 106 | 0 |
| K063034 | AIR-FLEX WITH AUTO-DISTRACTION | Hill Laboratories Co. | 2006-12-14 | 72 | 0 |
| K062476 | CERAGEM RH1 AUTOMATIC THERMAL MASSAGER | Ceragem International, Inc. | 2006-10-31 | 68 | 0 |
| K040031 | CERAGEM-C THERMAL ACUPRESSURE MASSAGER | Ceragem Co., Ltd. | 2004-07-28 | 202 | 0 |
| K041200 | THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 | Migun Medical Instrument Co. , Ltd. | 2004-06-17 | 41 | 0 |
| K032449 | THERMASSAGE ENERGY PRODUCT, MODEL HY5000 | Migun Medical Instrument Co. , Ltd. | 2003-10-22 | 75 | 0 |
| K010252 | MAGNUM | Magnum Equipment LLC | 2001-04-26 | 90 | 0 |
| K002390 | QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H | Lsi Intl., Inc. | 2000-11-02 | 90 | 0 |
| K993461 | QUEST INTERSEGMENTAL ROLLER TRACTION TABLE | Icon Intl., LLC | 2000-01-03 | 82 | 0 |
| K980021 | EXTENTRAC | Advanced Back Technologies | 1998-05-11 | 126 | 0 |
| K974626 | P.T. MACHINE | Goodman, Goodman & Goodman | 1998-02-06 | 57 | 0 |
| K971046 | HANDIFLEX | Handiflex Corp. | 1997-09-16 | 179 | 0 |
| K932810 | THE HILL ADJUSTABLE AIR-FLEX MODEL | Hill Laboratories Co. | 1995-02-17 | 618 | 0 |
| K945954 | MODELS 4100 AND 4300 MULTITHERAPY | Spinalight, Inc. | 1995-01-19 | 44 | 0 |
| K943973 | EURO TECH STERLING ROLLER TABLE | Progressive Electrical Therapeutics | 1994-09-29 | 45 | 0 |
| K933443 | COMBI 2.5 INTERSEGMENTAL TRACTION TABLE | Williams Healthcare Systems, LLC | 1994-02-02 | 203 | 0 |
| K924293 | HERITAGE 10 | Tjn Manufacturing,Inc. | 1993-05-26 | 273 | 0 |
| K926316 | TRUE-TRAC, STRATUS | Henley Intl. | 1993-03-24 | 99 | 0 |
| K930259 | TRACTION TABLE MODEL #825-200 | Biodan Medical Systems, Ltd. | 1993-03-24 | 64 | 0 |
| K922980 | 745-M (MAGNUM) | Tri W-G, Inc. | 1992-07-13 | 21 | 0 |
| K915784 | INTERSEGMENTAL TRACTION TABLE | Tjn Manufacturing,Inc. | 1992-01-14 | 21 | 0 |
| K911574 | PNEU-WAVE | Pneu-Mobility, Inc. | 1991-10-02 | 177 | 0 |
| K905756 | TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE | Titan Technology Intl., Inc. | 1991-01-08 | 12 | 0 |
| K901971 | COMFORTRAC TABLE MODEL CT-1000 | Comfortrac Systems | 1990-07-25 | 85 | 0 |
| K901526 | PRO TREATMENT TABLE | R&R Ent., Inc. | 1990-04-20 | 18 | 0 |
| K900304 | IST-200 INTERSEGMENTAL TRACTION TABLE | Chattanooga Group, Inc. | 1990-04-11 | 80 | 0 |
| K895343 | PRENATAL WEDGE | Kay Ent. | 1989-09-29 | 28 | 0 |
| K883357 | MODEL 1080 ROLLER MASSAGE TABLE | Excel Medical Products, Inc. | 1988-08-23 | 14 | 0 |
| K882917 | HI-LO TABLE, MODEL 820-05 | Tri W-G, Inc. | 1988-07-28 | 16 | 0 |
| K881804 | MULTI-FLEX TABLE--MODEL 200 | Slenderizers Equipment Mfg., Inc. | 1988-07-15 | 78 | 0 |
| K881902 | HEALTHTRONIC OMEGA TRAC | Healthtronics Surgical Services, Inc. | 1988-06-22 | 47 | 0 |
| K870714 | MULTI-FLEX TABLE -- MODEL 105 | Slenderizers Equipment Mfg., Inc. | 1987-06-09 | 109 | 0 |
| K870715 | MULTI-FLEX TABLE -- MODEL 106 | Slenderizers Equipment Mfg., Inc. | 1987-06-09 | 109 | 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