Product code BXB— Physical Medicine
PATIENT GUIDED KNEE EXERCISER
- Classification name
- Exerciser, Powered
- Device class
- Class 1
- Regulation
- 21 CFR 890.5380
- Advisory panel
- Physical Medicine
- Total cleared
- 160
- First cleared
- Most recent
Market context for product code BXB
FDA has cleared devices under product code BXB between 1980 and 2008, filed by 98 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2008
- 2001
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code BXB
Recent clearances under product code BXB
1–100 of 160- K072887 — G-TRAINER MEDICAL
- K003272 — FLO-BOOT
- K952975 — ANKLE CALF EXERCISER PHLEBOPUMP
- K953456 — E-Z FLEX
- K955105 — BTE CPM-10
- K955106 — BTE CPM-20
- K951028 — HAMEX TWO
- K950755 — FLEXMATE K500
- K945733 — AQUAHAB, MODEL 120-72-101
- K951029 — HAMEX ONE
- K950682 — W2 WRIST CPM UNIT
- K952369 — KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE
- K945690 — BACKCYCLER CPM(TM)
- K946169 — ACTIC 2002
- K945824 — GALAXY MD SERIES THERAPYPOOLS
- K944819 — KRDL 2000
- K945221 — SUTTER MODEL 6000 HAND CPM DEVICE
- K945121 — A3 ANKLE CPM UNIT
- K940455 — LATERAL FLEXION MACHINE
- K935011 — SWIMEX MULTIDEPTH POOL (MODEL 600T)
- K935587 — MULTILINK SHOULDER CPM UNIT
- K935509 — HYDROTRACK
- K935061 — LOWER BODY CYCLES
- K935216 — SEMI-RECUMBENT CYCLES
- K935520 — UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
- K933059 — ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.
- K942618 — ANKLE CALF EXERCISER
- K926136 — WATSYSTEM
- K931128 — BASIC SHOULDER CPM
- K935467 — R & D BATTERIES, INC. PART NUMBER 5447
- K934175 — STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER
- K935188 — STRETCHPOWER
- K935808 — REVOLUTION LOWER LIMB CPM UNIT
- K933394 — DANNIFLEX CPM 600
- K930780 — ADV400 TOE CPM
- K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS
- K931555 — ARTROMOT K2 CPM
- K931736 — M-FLEX 5000 C3PMD
- K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE
- K931723 — HYDRO-TRED/AIR POWERED TREADMILL
- K933311 — MOTORIZED ELECTRIC PARALLEL BARS
- K925270 — EX N' FLEX EF-200
- K924513 — LIDO(R) LINEA
- K925271 — REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE
- K925977 — PARAMED FLEXION-EXTENSION MACHINE
- K925807 — AQUACISER IN-POOL TREADMILL
- K924484 — ARTROMOT MULTI DIRECTIONAL ANKLE CPM
- K925926 — MOBILIMB T1 TOE CPM UNIT
- K925666 — THERAPACER 3000
- K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT
- K923805 — POWER PILLOW
- K923857 — ARTROMOT SB ELBOW ATTACHMENT
- K925043 — ELBOW CPM ORTHOSIS
- K923494 — PARAMED LATERAL FLEXION MACHINE
- K921348 — OIC MODEL J4 TMJ CPM
- K923216 — DANNINFLEX CPM 800
- K923217 — DANNIFLEX CPM 2000
- K922493 — AMERICAN MEDICAL MFG. LUMBAR CPM
- K920686 — ORTHO-PLEX-REHABILITATION SYSTEM
- K922185 — JACE KNEE EXTENSION SYSTEM -- MODIFICATION
- K921323 — CERVICAL PASSIVE MOTION
- K920860 — CONTROLLED PASSIVE MOTION MACHINE
- K920519 — LUMBAR CPM
- K920270 — CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY
- K920380 — JACE MODEL W550 WRIST CPM DEVICE
- K914860 — SUTTER MODEL 10000 LEG CPM DEVICE
- K914394 — BACK MASTER
- K912537 — JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION
- K913227 — JACE MODEL T300 TOE CPM DEVICE
- K912086 — FMA TRANSLATOR
- K904963 — EXTEND TRACK UNIT
- K905718 — ROMFLEX
- K904735 — DANNIFLEX MODEL 500TM CPM
- K910150 — ROMFLEX REHAB EQUIP EXTREMITIES UNIT
- K910026 — ATI MEDICAL COMFORT PLUS CPM PAD
- K910149 — ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
- K910151 — ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT
- K905299 — ROMFLEX REHABILITATION EQUIPMENT
- K893924 — MOTO-MED RF-II AND PICO
- K903851 — CLUB FOOT CPM MACHINE
- K903467 — JACE MODEL 100 KNEE CPM DEVICE
- K902707 — MODEL 9000 AT ANKLE CPM DEVICE
- K902452 — CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER
- K900466 — MOBILIMB W1 WRIST CPM UNIT
- K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT
- K895720 — MOBILIMB J1 TMJ CPM UNIT
- K894907 — MARK IV HAND, THUMB AND WRIST (CPM) UNIT
- K895015 — ARTROMOT(TM) CPM DEVICES
- K891345 — MOBILIMB CPM SHOULDER UNIT
- K890838 — REHABOT-YM
- K885182 — TOTAL KNEE CPM
- K890607 — SUTTER HOSPITAL CPM
- K885095 — SUPREME TONING SYSTEMS
- K890200 — PNEUMATIC DORSIFLEXOR
- K881314 — PROMO-RIST C.P.M.
- K882406 — CONVA-LIFT
- K882916 — MOTORIZED PARALLEL BAR, MODEL 110
- K880865 — RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
- K873658 — ANKLE REFLEX TREATMENT UNIT (ARTU)
- K880092 — RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100
Data sourced from openFDA. This site is unofficial and independent of the FDA.