FDA Product Code BXB: Exerciser, Powered
Leading manufacturers include Invacare Corp., Buckman Co., Inc. and Richards Medical Co., Inc..
160
Total
160
Cleared
119d
Avg days
1980
Since
FDA 510(k) Cleared Exerciser, Powered Devices (Product Code BXB)
160 devices
Cleared
Apr 19, 1994
R & D BATTERIES, INC. PART NUMBER 5447
R & D Batteries, Inc.
Physical Medicine
169d
Cleared
Feb 04, 1994
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
Henley Intl.
Physical Medicine
416d
Cleared
Mar 22, 1993
ARTROMOT MULTI DIRECTIONAL ANKLE CPM
Buckman Co., Inc.
Physical Medicine
200d
Cleared
Feb 12, 1993
ARTROMOT SB ELBOW ATTACHMENT
Buckman Co., Inc.
Physical Medicine
196d
Cleared
Aug 03, 1992
DANNINFLEX CPM 800
Buckman Co., Inc.
Physical Medicine
33d
Cleared
Aug 03, 1992
DANNIFLEX CPM 2000
Buckman Co., Inc.
Physical Medicine
33d
Cleared
Jan 30, 1991
DANNIFLEX MODEL 500TM CPM
Buckman Co., Inc.
Physical Medicine
105d
Cleared
Oct 19, 1990
CLUB FOOT CPM MACHINE
Smith & Nephew Richards, Inc.
Physical Medicine
59d
Cleared
Sep 11, 1989
ARTROMOT(TM) CPM DEVICES
Buckman Co., Inc.
Physical Medicine
34d
Cleared
Mar 15, 1989
TOTAL KNEE CPM
Invacare Corp.
Physical Medicine
91d
Cleared
Jul 28, 1988
MOTORIZED PARALLEL BAR, MODEL 110
Tri W-G, Inc.
Physical Medicine
16d
Cleared
May 02, 1988
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
Invacare Corp.
Physical Medicine
62d
Cleared
Apr 11, 1988
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100
Invacare Corp.
Physical Medicine
90d
Cleared
Sep 18, 1987
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
Invacare Corp.
Physical Medicine
79d
Cleared
Sep 18, 1987
MOTORIZED TREADMILL MODEL #FT2200
Invacare Corp.
Physical Medicine
74d
Cleared
Sep 18, 1987
DELUXE MOTORIZED TREADMILL MODEL #FT2300
Invacare Corp.
Physical Medicine
74d
Cleared
Feb 26, 1987
DANNIFLEX 400I
Buckman Co., Inc.
Physical Medicine
21d
Cleared
Dec 02, 1986
KNEECPM
Invacare Corp.
Physical Medicine
20d
Cleared
Jul 15, 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
Richards Medical Co., Inc.
Physical Medicine
27d
Cleared
Aug 09, 1985
TOTAL CPM
Invacare Corp.
Physical Medicine
64d
Cleared
Jul 17, 1985
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
Empi
Physical Medicine
104d
Cleared
May 01, 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
Richards Medical Co., Inc.
Physical Medicine
93d
Cleared
Oct 16, 1984
UNIFLEX DANNINGER
Buckman Co., Inc.
Physical Medicine
54d
Cleared
Sep 12, 1984
PATIENT GUIDED KNEE EXERCISER
Richards Medical Co., Inc.
Physical Medicine
6d