BXB — Exerciser, Powered Class I

FDA Device Classification

Classification Details

Product Code
BXB
Device Class
Class I
Regulation Number
890.5380
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K072887alter-gG-TRAINER MEDICALJanuary 25, 2008
K003272discovery groupFLO-BOOTApril 4, 2001
K952975prevent productsANKLE CALF EXERCISER PHLEBOPUMPSeptember 25, 1996
K953456fluid motion biotechnologiesE-Z FLEXJanuary 26, 1996
K955106baltimore therapeutic equipmentBTE CPM-20December 29, 1995
K955105baltimore therapeutic equipmentBTE CPM-10December 29, 1995
K951028northern orthopaedic productsHAMEX TWODecember 11, 1995
K950755bregFLEXMATE K500October 5, 1995
K945733aquarius electronicsAQUAHAB, MODEL 120-72-101September 15, 1995
K951029northern orthopaedic productsHAMEX ONESeptember 15, 1995
K950682toronto medicalW2 WRIST CPM UNITSeptember 13, 1995
K952369physicians consultingKRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLEAugust 7, 1995
K945690ergomedicsBACKCYCLER CPM(TM)June 22, 1995
K946169north atlantic rehabilitationACTIC 2002June 15, 1995
K945824galaxy aquaticsGALAXY MD SERIES THERAPYPOOLSApril 5, 1995
K944819physicians consultingKRDL 2000March 10, 1995
K945221sutterSUTTER MODEL 6000 HAND CPM DEVICEFebruary 27, 1995
K945121toronto medicalA3 ANKLE CPM UNITFebruary 17, 1995
K940455rehabLATERAL FLEXION MACHINEJanuary 12, 1995
K935011swimex systemsSWIMEX MULTIDEPTH POOL (MODEL 600T)January 9, 1995