JFB · Class II · 21 CFR 890.5880

FDA Product Code JFB: Table, Physical Therapy, Multi Function

Leading manufacturers include Ceragem Co., Ltd., Nuga Medical Co., Ltd. and Tri W-G, Inc..

66
Total
66
Cleared
122d
Avg days
1982
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 128d avg (recent)

FDA 510(k) Cleared Table, Physical Therapy, Multi Function Devices (Product Code JFB)

66 devices
1–24 of 66
Cleared Jul 11, 2025
Ceragem Automatic Thermal Massager (CGM MB-2401)
K250266
Ceragem Co., Ltd.
Physical Medicine · 162d
Cleared Jan 31, 2025
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K241193
Marzzan Lucas Jorge
Physical Medicine · 277d
Cleared Jan 08, 2025
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K243644
Ceragem Co., Ltd.
Physical Medicine · 43d
Cleared Nov 27, 2024
Ceragem Automatic Thermal Massager (CGM-MB-1902)
K243355
Ceragem Co., Ltd.
Physical Medicine · 29d
Cleared Sep 12, 2024
N7-S
K240168
Nuga Medical Co., Ltd.
Physical Medicine · 234d
Cleared Jun 17, 2022
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
K220572
Ceragem Co., Ltd.
Physical Medicine · 109d
Cleared Mar 18, 2021
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
K202937
Ceragem Co., Ltd.
Physical Medicine · 169d
Cleared Mar 02, 2021
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
K202113
Ceragem Co., Ltd.
Physical Medicine · 215d
Cleared Feb 05, 2016
N5-1
K153054
Nuga Medical Co., Ltd.
Physical Medicine · 108d
Cleared Dec 17, 2014
CERAGEM AUTOMATIC THERMAL MASSAGER
K140592
Ceragem International, Inc.
Physical Medicine · 285d
Cleared Oct 26, 2012
LEGACY-500
K111588
Mt Tables, LLC
Physical Medicine · 507d
Cleared May 25, 2012
CHOYANG THERMAL MASSAGER
K111941
Choyang Medical Instrument Co., Ltd.
Physical Medicine · 322d
Cleared Sep 06, 2011
NM-7000
K111329
Nuga Medical Co., Ltd.
Physical Medicine · 118d
Cleared Jun 10, 2010
VIBRO-TRAC
K092731
Pneumex, Inc.
Physical Medicine · 279d
Cleared Aug 27, 2008
INAREX, MODEL 2D-LX
K080554
Inarex Corporation
Physical Medicine · 181d
Cleared Jun 26, 2007
MASSAGE MATTRESS VM9100RM
K070672
Metek GmbH
Physical Medicine · 106d
Cleared Dec 14, 2006
AIR-FLEX WITH AUTO-DISTRACTION
K063034
Hill Laboratories Co.
Physical Medicine · 72d
Cleared Oct 31, 2006
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
K062476
Ceragem International, Inc.
Physical Medicine · 68d
Cleared Jun 17, 2004
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
K041200
Migun Medical Instrument Co. , Ltd.
Physical Medicine · 41d
Cleared Jan 03, 2000
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K993461
Icon Intl., LLC
Physical Medicine · 82d
Cleared May 11, 1998
EXTENTRAC
K980021
Advanced Back Technologies
Physical Medicine · 126d
Cleared Feb 06, 1998
P.T. MACHINE
K974626
Goodman, Goodman & Goodman
Physical Medicine · 57d
Cleared Sep 16, 1997
HANDIFLEX
K971046
Handiflex Corp.
Physical Medicine · 179d
Cleared Feb 17, 1995
THE HILL ADJUSTABLE AIR-FLEX MODEL
K932810
Hill Laboratories Co.
Physical Medicine · 618d

About Product Code JFB - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code JFB since 1982, with 66 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JFB Product Code

FDA review times for JFB submissions have been consistent, averaging 128 days recently vs 121 days historically.

JFB devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →