Atlas FDA

JFB

66 FDA 510(k) clearances · Product code

90 daysmedian time to decision
279 days90th percentile
66clearances measured

FDA profile

Official device name
Table, Physical Therapy, Multi Function
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5880
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 2 · 2005: 4 · 2006: 3 · 2007: 3 · 2008: 3 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ceragem Automatic Thermal Massager (CGM MB-2401) (K250266)Ceragem Co., Ltd.2025-07-11
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (K241193)Marzzan Lucas Jorge2025-01-31
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (K243644)Ceragem Co., Ltd.2025-01-08
Ceragem Automatic Thermal Massager (CGM-MB-1902) (K243355)Ceragem Co., Ltd.2024-11-27
N7-S (K240168)Nuga Medical Co., Ltd.2024-09-12
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (K220572)Ceragem Co., Ltd.2022-06-17
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (K202937)Ceragem Co., Ltd.2021-03-18
Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (K202113)Ceragem Co., Ltd.2021-03-02
N5-1 (K153054)Nuga Medical Co., Ltd.2016-02-05
CERAGEM AUTOMATIC THERMAL MASSAGER (K140592)Ceragem International, Inc.2014-12-17
LEGACY-500 (K111588)Mt Tables, LLC2012-10-26
CHOYANG THERMAL MASSAGER (K111941)Choyang Medical Instrument Co., Ltd.2012-05-25
ACQPOINT THERMAJADE MASSAGE TABLE (K102938)Acqpoint, Inc.2011-09-23
NM-7000 (K111329)Nuga Medical Co., Ltd.2011-09-06
THERMAL MASSAGE BED, MODEL 2D-GX (K102281)Inarex Corporation2010-12-22
VIBRO-TRAC (K092731)Pneumex, Inc.2010-06-10
INAREX, MODEL 2D-LX (K080554)Inarex Corporation2008-08-27
MASSAGE MATTRESS VM9100RM (K070672)Metek GmbH2007-06-26
AIR-FLEX WITH AUTO-DISTRACTION (K063034)Hill Laboratories Co.2006-12-14
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER (K062476)Ceragem International, Inc.2006-10-31
CERAGEM-C THERMAL ACUPRESSURE MASSAGER (K040031)Ceragem Co., Ltd.2004-07-28
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 (K041200)Migun Medical Instrument Co. , Ltd.2004-06-17
THERMASSAGE ENERGY PRODUCT, MODEL HY5000 (K032449)Migun Medical Instrument Co. , Ltd.2003-10-22
MAGNUM (K010252)Magnum Equipment LLC2001-04-26
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H (K002390)Lsi Intl., Inc.2000-11-02
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE (K993461)Icon Intl., LLC2000-01-03
EXTENTRAC (K980021)Advanced Back Technologies1998-05-11
P.T. MACHINE (K974626)Goodman, Goodman & Goodman1998-02-06
HANDIFLEX (K971046)Handiflex Corp.1997-09-16
THE HILL ADJUSTABLE AIR-FLEX MODEL (K932810)Hill Laboratories Co.1995-02-17
MODELS 4100 AND 4300 MULTITHERAPY (K945954)Spinalight, Inc.1995-01-19
EURO TECH STERLING ROLLER TABLE (K943973)Progressive Electrical Therapeutics1994-09-29
COMBI 2.5 INTERSEGMENTAL TRACTION TABLE (K933443)Williams Healthcare Systems, LLC1994-02-02
HERITAGE 10 (K924293)Tjn Manufacturing,Inc.1993-05-26
TRUE-TRAC, STRATUS (K926316)Henley Intl.1993-03-24
TRACTION TABLE MODEL #825-200 (K930259)Biodan Medical Systems, Ltd.1993-03-24
745-M (MAGNUM) (K922980)Tri W-G, Inc.1992-07-13
INTERSEGMENTAL TRACTION TABLE (K915784)Tjn Manufacturing,Inc.1992-01-14
PNEU-WAVE (K911574)Pneu-Mobility, Inc.1991-10-02
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE (K905756)Titan Technology Intl., Inc.1991-01-08
COMFORTRAC TABLE MODEL CT-1000 (K901971)Comfortrac Systems1990-07-25
PRO TREATMENT TABLE (K901526)R&R Ent., Inc.1990-04-20
IST-200 INTERSEGMENTAL TRACTION TABLE (K900304)Chattanooga Group, Inc.1990-04-11
PRENATAL WEDGE (K895343)Kay Ent.1989-09-29
MODEL 1080 ROLLER MASSAGE TABLE (K883357)Excel Medical Products, Inc.1988-08-23
HI-LO TABLE, MODEL 820-05 (K882917)Tri W-G, Inc.1988-07-28
MULTI-FLEX TABLE--MODEL 200 (K881804)Slenderizers Equipment Mfg., Inc.1988-07-15
HEALTHTRONIC OMEGA TRAC (K881902)Healthtronics Surgical Services, Inc.1988-06-22
MULTI-FLEX TABLE -- MODEL 105 (K870714)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 106 (K870715)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 103 (K870712)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 104 (K870713)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 102 (K870711)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 101 (K870710)Slenderizers Equipment Mfg., Inc.1987-06-09
EXTENSION/OSCILLATOR TABLE (K870427)Heidelberg Medical Products1987-02-13
THE RELAXARE EXERCISE AND MASSAGE UNIT (K862411)Relaxare Corp.1986-07-09
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (K862022)Lic-Orthion1986-06-19
PORT-A-TRAC (K861554)Port-A-Trac Co.1986-06-19
KINETIC AUTO TECHNIC K.A.T. TABLE (K851328)Buckman Co., Inc.1985-07-17
AUTOTRACTION TABLE (K844233)Chattanooga Group, Inc.1984-12-11
PDB II VIBRATING DRAINAGE BED (K843572)Invacare Corp.1984-11-23
MASSAGE TABLE AAT-100 (K832464)R&D Systems, Inc.1983-08-16
WEYLAND EXTENSION VIBRATOR (K822413)Medical Management Service, Inc.1983-06-08
SOMATRON (K831394)Somatron Co.1983-06-08
S & W MODEL 29 (K830875)S & W Enterprises, Inc.1983-04-08
ACU-MASSAGE TABLE (K822693)H.W.E., Inc.1982-09-21

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