Product Code: JFB FDA class 2 21 CFR 890.5880

Table, Physical Therapy, Multi Function

Physical Medicine

A Multi-Function Physical Therapy Table is an adjustable treatment table used in physical and rehabilitative medicine settings to position patients for a variety of therapeutic procedures including manual therapy, exercise, traction, and electrotherapy. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, requiring 510(k) premarket notification. The product code is JFB, regulated under 21 CFR 890.5880, within the Physical Medicine medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JFB
Device Class: FDA class 2
Regulation Number: 890.5880
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 66 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250266	Ceragem Automatic Thermal Massager (CGM MB-2401)	Jul 11, 2025	Substantially Equivalent	Ceragem Co., Ltd.
K241193	AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)	Jan 31, 2025	Substantially Equivalent	Marzzan Lucas Jorge
K243644	Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)	Jan 08, 2025	Substantially Equivalent	Ceragem Co., Ltd.
K243355	Ceragem Automatic Thermal Massager (CGM-MB-1902)	Nov 27, 2024	Substantially Equivalent	Ceragem Co., Ltd.
K240168	N7-S	Sep 12, 2024	Substantially Equivalent	Nuga Medical Co., Ltd.
K220572	Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702	Jun 17, 2022	Substantially Equivalent	Ceragem Co., Ltd.
K202937	Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702	Mar 18, 2021	Substantially Equivalent	Ceragem Co., Ltd.
K202113	Ceragem Automatic Thermal Massager, Model CGM-MB-1901	Mar 02, 2021	Substantially Equivalent	Ceragem Co., Ltd.
K153054	N5-1	Feb 05, 2016	Substantially Equivalent	Nuga Medical Co., Ltd.
K140592	CERAGEM AUTOMATIC THERMAL MASSAGER	Dec 17, 2014	Substantially Equivalent	Ceragem International, Inc.
K111588	LEGACY-500	Oct 26, 2012	Substantially Equivalent	Mt Tables, LLC
K111941	CHOYANG THERMAL MASSAGER	May 25, 2012	Substantially Equivalent	Choyang Medical Instrument Co., Ltd.
K102938	ACQPOINT THERMAJADE MASSAGE TABLE	Sep 23, 2011	Substantially Equivalent	Acqpoint, Inc.
K111329	NM-7000	Sep 06, 2011	Substantially Equivalent	Nuga Medical Co., Ltd.
K102281	THERMAL MASSAGE BED, MODEL 2D-GX	Dec 22, 2010	Substantially Equivalent	Inarex Corporation
K092731	VIBRO-TRAC	Jun 10, 2010	Substantially Equivalent	Pneumex, Inc.
K080554	INAREX, MODEL 2D-LX	Aug 27, 2008	Substantially Equivalent	Inarex Corporation
K070672	MASSAGE MATTRESS VM9100RM	Jun 26, 2007	Substantially Equivalent	Metek GmbH
K063034	AIR-FLEX WITH AUTO-DISTRACTION	Dec 14, 2006	Substantially Equivalent	Hill Laboratories Co.
K062476	CERAGEM RH1 AUTOMATIC THERMAL MASSAGER	Oct 31, 2006	Substantially Equivalent	Ceragem International, Inc.
K040031	CERAGEM-C THERMAL ACUPRESSURE MASSAGER	Jul 28, 2004	Substantially Equivalent	Ceragem Co., Ltd.
K041200	THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000	Jun 17, 2004	Substantially Equivalent	Migun Medical Instrument Co. , Ltd.
K032449	THERMASSAGE ENERGY PRODUCT, MODEL HY5000	Oct 22, 2003	Substantially Equivalent	Migun Medical Instrument Co. , Ltd.
K010252	MAGNUM	Apr 26, 2001	Substantially Equivalent	Magnum Equipment LLC
K002390	QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H	Nov 02, 2000	Substantially Equivalent	Lsi Intl., Inc.
K993461	QUEST INTERSEGMENTAL ROLLER TRACTION TABLE	Jan 03, 2000	Substantially Equivalent	Icon Intl., LLC
K980021	EXTENTRAC	May 11, 1998	Substantially Equivalent	Advanced Back Technologies
K974626	P.T. MACHINE	Feb 06, 1998	Substantially Equivalent	Goodman, Goodman & Goodman
K971046	HANDIFLEX	Sep 16, 1997	Substantially Equivalent	Handiflex Corp.
K932810	THE HILL ADJUSTABLE AIR-FLEX MODEL	Feb 17, 1995	Substantially Equivalent	Hill Laboratories Co.
K945954	MODELS 4100 AND 4300 MULTITHERAPY	Jan 19, 1995	Substantially Equivalent	Spinalight, Inc.
K943973	EURO TECH STERLING ROLLER TABLE	Sep 29, 1994	Substantially Equivalent	Progressive Electrical Therapeutics
K933443	COMBI 2.5 INTERSEGMENTAL TRACTION TABLE	Feb 02, 1994	Substantially Equivalent	Williams Healthcare Systems, LLC
K924293	HERITAGE 10	May 26, 1993	Substantially Equivalent	Tjn Manufacturing,Inc.
K930259	TRACTION TABLE MODEL #825-200	Mar 24, 1993	Substantially Equivalent	Biodan Medical Systems, Ltd.
K926316	TRUE-TRAC, STRATUS	Mar 24, 1993	Substantially Equivalent	Henley Intl.
K922980	745-M (MAGNUM)	Jul 13, 1992	Substantially Equivalent	Tri W-G, Inc.
K915784	INTERSEGMENTAL TRACTION TABLE	Jan 14, 1992	Substantially Equivalent	Tjn Manufacturing,Inc.
K911574	PNEU-WAVE	Oct 02, 1991	Substantially Equivalent	Pneu-Mobility, Inc.
K905756	TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE	Jan 08, 1991	Substantially Equivalent	Titan Technology Intl., Inc.
K901971	COMFORTRAC TABLE MODEL CT-1000	Jul 25, 1990	Substantially Equivalent	Comfortrac Systems
K901526	PRO TREATMENT TABLE	Apr 20, 1990	Substantially Equivalent	R&R Ent., Inc.
K900304	IST-200 INTERSEGMENTAL TRACTION TABLE	Apr 11, 1990	Substantially Equivalent	Chattanooga Group, Inc.
K895343	PRENATAL WEDGE	Sep 29, 1989	Substantially Equivalent	Kay Ent.
K883357	MODEL 1080 ROLLER MASSAGE TABLE	Aug 23, 1988	Substantially Equivalent	Excel Medical Products, Inc.
K882917	HI-LO TABLE, MODEL 820-05	Jul 28, 1988	Substantially Equivalent	Tri W-G, Inc.
K881804	MULTI-FLEX TABLE--MODEL 200	Jul 15, 1988	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K881902	HEALTHTRONIC OMEGA TRAC	Jun 22, 1988	Substantially Equivalent	Healthtronics Surgical Services, Inc.
K870715	MULTI-FLEX TABLE -- MODEL 106	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870714	MULTI-FLEX TABLE -- MODEL 105	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870713	MULTI-FLEX TABLE -- MODEL 104	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870712	MULTI-FLEX TABLE -- MODEL 103	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870711	MULTI-FLEX TABLE -- MODEL 102	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870710	MULTI-FLEX TABLE -- MODEL 101	Jun 09, 1987	Substantially Equivalent	Slenderizers Equipment Mfg., Inc.
K870427	EXTENSION/OSCILLATOR TABLE	Feb 13, 1987	Substantially Equivalent	Heidelberg Medical Products
K862411	THE RELAXARE EXERCISE AND MASSAGE UNIT	Jul 09, 1986	Substantially Equivalent	Relaxare Corp.
K862022	LIC-ORTHION MULTI-THERAPY TREATMENT TABLE	Jun 19, 1986	Substantially Equivalent	Lic-Orthion
K861554	PORT-A-TRAC	Jun 19, 1986	Substantially Equivalent	Port-A-Trac Co.
K851328	KINETIC AUTO TECHNIC K.A.T. TABLE	Jul 17, 1985	Substantially Equivalent	Buckman Co., Inc.
K844233	AUTOTRACTION TABLE	Dec 11, 1984	Substantially Equivalent	Chattanooga Group, Inc.
K843572	PDB II VIBRATING DRAINAGE BED	Nov 23, 1984	Substantially Equivalent	Invacare Corp.
K832464	MASSAGE TABLE AAT-100	Aug 16, 1983	Substantially Equivalent	R&D Systems, Inc.
K831394	SOMATRON	Jun 08, 1983	Substantially Equivalent	Somatron Co.
K822413	WEYLAND EXTENSION VIBRATOR	Jun 08, 1983	Substantially Equivalent	Medical Management Service, Inc.
K830875	S & W MODEL 29	Apr 08, 1983	Substantially Equivalent	S & W Enterprises, Inc.
K822693	ACU-MASSAGE TABLE	Sep 21, 1982	Substantially Equivalent	H.W.E., Inc.