BXB · Class I · 21 CFR 890.5380

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
1–24 of 160
Cleared Apr 19, 1994
R & D BATTERIES, INC. PART NUMBER 5447
K935467
R & D Batteries, Inc.
Physical Medicine · 169d
Cleared Feb 04, 1994
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K926313
Henley Intl.
Physical Medicine · 416d
Cleared Mar 22, 1993
ARTROMOT MULTI DIRECTIONAL ANKLE CPM
K924484
Buckman Co., Inc.
Physical Medicine · 200d
Cleared Feb 12, 1993
ARTROMOT SB ELBOW ATTACHMENT
K923857
Buckman Co., Inc.
Physical Medicine · 196d
Cleared Aug 03, 1992
DANNINFLEX CPM 800
K923216
Buckman Co., Inc.
Physical Medicine · 33d
Cleared Aug 03, 1992
DANNIFLEX CPM 2000
K923217
Buckman Co., Inc.
Physical Medicine · 33d
Cleared Jan 30, 1991
DANNIFLEX MODEL 500TM CPM
K904735
Buckman Co., Inc.
Physical Medicine · 105d
Cleared Oct 19, 1990
CLUB FOOT CPM MACHINE
K903851
Smith & Nephew Richards, Inc.
Physical Medicine · 59d
Cleared Sep 11, 1989
ARTROMOT(TM) CPM DEVICES
K895015
Buckman Co., Inc.
Physical Medicine · 34d
Cleared Mar 15, 1989
TOTAL KNEE CPM
K885182
Invacare Corp.
Physical Medicine · 91d
Cleared Jul 28, 1988
MOTORIZED PARALLEL BAR, MODEL 110
K882916
Tri W-G, Inc.
Physical Medicine · 16d
Cleared May 02, 1988
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
K880865
Invacare Corp.
Physical Medicine · 62d
Cleared Apr 11, 1988
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100
K880092
Invacare Corp.
Physical Medicine · 90d
Cleared Sep 18, 1987
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
K872586
Invacare Corp.
Physical Medicine · 79d
Cleared Sep 18, 1987
MOTORIZED TREADMILL MODEL #FT2200
K872638
Invacare Corp.
Physical Medicine · 74d
Cleared Sep 18, 1987
DELUXE MOTORIZED TREADMILL MODEL #FT2300
K872639
Invacare Corp.
Physical Medicine · 74d
Cleared Feb 26, 1987
DANNIFLEX 400I
K870510
Buckman Co., Inc.
Physical Medicine · 21d
Cleared Dec 02, 1986
KNEECPM
K864427
Invacare Corp.
Physical Medicine · 20d
Cleared Jul 15, 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314
Richards Medical Co., Inc.
Physical Medicine · 27d
Cleared Aug 09, 1985
TOTAL CPM
K852399
Invacare Corp.
Physical Medicine · 64d
Cleared Jul 17, 1985
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
K851331
Empi
Physical Medicine · 104d
Cleared May 01, 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K850332
Richards Medical Co., Inc.
Physical Medicine · 93d
Cleared Oct 16, 1984
UNIFLEX DANNINGER
K843309
Buckman Co., Inc.
Physical Medicine · 54d
Cleared Sep 12, 1984
PATIENT GUIDED KNEE EXERCISER
K843493
Richards Medical Co., Inc.
Physical Medicine · 6d

About Product Code BXB - Regulatory Context