JFB · Class II · 21 CFR 890.5880

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

Leading manufacturers include Ceragem Co., Ltd., Chattanooga Group, Inc. and Tri W-G, Inc..

66
Total
66
Cleared
122d
Avg days
1982
Since
Growing category - 5 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 149d recently vs 119d historically

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 Mar 24, 1993
TRUE-TRAC, STRATUS
K926316
Henley Intl.
Physical Medicine · 99d
Cleared Jul 13, 1992
745-M (MAGNUM)
K922980
Tri W-G, Inc.
Physical Medicine · 21d
Cleared Apr 11, 1990
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Jul 28, 1988
HI-LO TABLE, MODEL 820-05
K882917
Tri W-G, Inc.
Physical Medicine · 16d
Cleared Jul 17, 1985
KINETIC AUTO TECHNIC K.A.T. TABLE
K851328
Buckman Co., Inc.
Physical Medicine · 104d
Cleared Dec 11, 1984
AUTOTRACTION TABLE
K844233
Chattanooga Group, Inc.
Physical Medicine · 41d
Cleared Nov 23, 1984
PDB II VIBRATING DRAINAGE BED
K843572
Invacare Corp.
Physical Medicine · 73d
Cleared Aug 16, 1983
MASSAGE TABLE AAT-100
K832464
R&D Systems, Inc.
Physical Medicine · 21d

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 - 5 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JFB Product Code

Recent submissions under JFB have taken an average of 149 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

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