BXB · Class I · 21 CFR 890.5380

FDA Product Code BXB: Exerciser, Powered

Leading manufacturers include Allied Associates, Inc., Invacare Corp. and Buckman 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 Jan 25, 2008
G-TRAINER MEDICAL
K072887
Alter-G, Inc.
Physical Medicine · 107d
Cleared Apr 04, 2001
FLO-BOOT
K003272
Discovery Group, LLC
Physical Medicine · 168d
Cleared Sep 25, 1996
ANKLE CALF EXERCISER PHLEBOPUMP
K952975
Prevent Products, Inc.
Physical Medicine · 456d
Cleared Jan 26, 1996
E-Z FLEX
K953456
Fluid Motion Biotechnologies, Inc.
Physical Medicine · 191d
Cleared Dec 29, 1995
BTE CPM-10
K955105
Baltimore Therapeutic Equipment Co.
Physical Medicine · 51d
Cleared Dec 29, 1995
BTE CPM-20
K955106
Baltimore Therapeutic Equipment Co.
Physical Medicine · 51d
Cleared Dec 11, 1995
HAMEX TWO
K951028
Northern Orthopaedic Products, Inc.
Physical Medicine · 279d
Cleared Oct 05, 1995
FLEXMATE K500
K950755
Breg, Inc.
Physical Medicine · 230d
Cleared Sep 15, 1995
AQUAHAB, MODEL 120-72-101
K945733
Aquarius Electronics, Inc.
Physical Medicine · 296d
Cleared Sep 15, 1995
HAMEX ONE
K951029
Northern Orthopaedic Products, Inc.
Physical Medicine · 192d
Cleared Sep 13, 1995
W2 WRIST CPM UNIT
K950682
Toronto Medical Corp.
Physical Medicine · 211d
Cleared Aug 07, 1995
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE
K952369
Physicians Consulting, Inc.
Physical Medicine · 98d
Cleared Jun 22, 1995
BACKCYCLER CPM(TM)
K945690
Ergomedics, Inc.
Physical Medicine · 213d
Cleared Jun 15, 1995
ACTIC 2002
K946169
North Atlantic Rehabilitation, Inc.
Physical Medicine · 178d
Cleared Apr 05, 1995
GALAXY MD SERIES THERAPYPOOLS
K945824
Galaxy Aquatics, Inc.
Physical Medicine · 127d
Cleared Mar 10, 1995
KRDL 2000
K944819
Physicians Consulting, Inc.
Physical Medicine · 162d
Cleared Feb 27, 1995
SUTTER MODEL 6000 HAND CPM DEVICE
K945221
Sutter Corp.
Physical Medicine · 124d
Cleared Feb 17, 1995
A3 ANKLE CPM UNIT
K945121
Toronto Medical, Inc.
Physical Medicine · 121d
Cleared Jan 12, 1995
LATERAL FLEXION MACHINE
K940455
Rehab, Inc.
Physical Medicine · 345d
Cleared Jan 09, 1995
SWIMEX MULTIDEPTH POOL (MODEL 600T)
K935011
Swimex Systems
Physical Medicine · 446d
Cleared Dec 14, 1994
MULTILINK SHOULDER CPM UNIT
K935587
Toronto Medical Corp.
Physical Medicine · 393d
Cleared Oct 03, 1994
HYDROTRACK
K935509
Ferno Ille
Physical Medicine · 322d
Cleared Sep 16, 1994
LOWER BODY CYCLES
K935061
Biodex Medical Systems, Inc.
Physical Medicine · 330d
Cleared Sep 16, 1994
SEMI-RECUMBENT CYCLES
K935216
Biodex Medical Systems, Inc.
Physical Medicine · 325d

About Product Code BXB - Regulatory Context