Atlas FDA

BXB

160 FDA 510(k) clearances · Product code

74 daysmedian time to decision
307 days90th percentile
160clearances measured

FDA profile

Official device name
Exerciser, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.5380
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2008: 10 · 2009: 4 · 2010: 7 · 2011: 5 · 2013: 8 · 2023: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
G-TRAINER MEDICAL (K072887)Alter-G, Inc.2008-01-25
FLO-BOOT (K003272)Discovery Group, LLC2001-04-04
ANKLE CALF EXERCISER PHLEBOPUMP (K952975)Prevent Products, Inc.1996-09-25
E-Z FLEX (K953456)Fluid Motion Biotechnologies, Inc.1996-01-26
BTE CPM-20 (K955106)Baltimore Therapeutic Equipment Co.1995-12-29
BTE CPM-10 (K955105)Baltimore Therapeutic Equipment Co.1995-12-29
HAMEX TWO (K951028)Northern Orthopaedic Products, Inc.1995-12-11
FLEXMATE K500 (K950755)Breg, Inc.1995-10-05
HAMEX ONE (K951029)Northern Orthopaedic Products, Inc.1995-09-15
AQUAHAB, MODEL 120-72-101 (K945733)Aquarius Electronics, Inc.1995-09-15
W2 WRIST CPM UNIT (K950682)Toronto Medical Corp.1995-09-13
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (K952369)Physicians Consulting, Inc.1995-08-07
BACKCYCLER CPM(TM) (K945690)Ergomedics, Inc.1995-06-22
ACTIC 2002 (K946169)North Atlantic Rehabilitation, Inc.1995-06-15
GALAXY MD SERIES THERAPYPOOLS (K945824)Galaxy Aquatics, Inc.1995-04-05
KRDL 2000 (K944819)Physicians Consulting, Inc.1995-03-10
SUTTER MODEL 6000 HAND CPM DEVICE (K945221)Sutter Corp.1995-02-27
A3 ANKLE CPM UNIT (K945121)Toronto Medical, Inc.1995-02-17
LATERAL FLEXION MACHINE (K940455)Rehab, Inc.1995-01-12
SWIMEX MULTIDEPTH POOL (MODEL 600T) (K935011)Swimex Systems1995-01-09
MULTILINK SHOULDER CPM UNIT (K935587)Toronto Medical Corp.1994-12-14
HYDROTRACK (K935509)Ferno Ille1994-10-03
LOWER BODY CYCLES (K935061)Biodex Medical Systems, Inc.1994-09-16
UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (K935520)Biodex Medical Systems, Inc.1994-09-16
SEMI-RECUMBENT CYCLES (K935216)Biodex Medical Systems, Inc.1994-09-16
ANKLE CALF EXERCISER (K942618)Prevent Products, Inc.1994-06-22
ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. (K933059)Jace Systems, Inc.1994-06-22
WATSYSTEM (K926136)Watsystem Div. of Itc1994-05-20
BASIC SHOULDER CPM (K931128)Danninger Medical Technology, Inc.1994-05-06
R & D BATTERIES, INC. PART NUMBER 5447 (K935467)R & D Batteries, Inc.1994-04-19
STRETCHPOWER (K935188)Orthopedic Development, Inc.1994-03-24
STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER (K934175)Orthopedic Development, Inc.1994-03-24
REVOLUTION LOWER LIMB CPM UNIT (K935808)Toronto Medical, Inc.1994-03-18
DANNIFLEX CPM 600 (K933394)Danninger Medical Technology, Inc.1994-03-11
ADV400 TOE CPM (K930780)Advanced Kinetics, Inc.1994-02-17
COMPUTERIZED TESTING AND EXERCISE SYSTEMS (K926313)Henley Intl.1994-02-04
ARTROMOT K2 CPM (K931555)Ormed Mfg., Inc.1994-01-31
M-FLEX 5000 C3PMD (K931736)Medical Systems Corp.1994-01-27
HYDRO-TRED/AIR POWERED TREADMILL (K931723)Santa FE Swim Systems1994-01-26
FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (K926262)Sgarlato Laboratories, Inc.1994-01-26
MOTORIZED ELECTRIC PARALLEL BARS (K933311)Midland Mfg. Co.1994-01-26
EX N' FLEX EF-200 (K925270)Tecogics Scientific , Ltd.1993-07-21
LIDO(R) LINEA (K924513)Loredan Biomedical, Inc.1993-03-31
REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE (K925271)Repex Intl., Inc.1993-03-31
PARAMED FLEXION-EXTENSION MACHINE (K925977)Paramed Services, Inc.1993-03-31
AQUACISER IN-POOL TREADMILL (K925807)Aquaciser, Inc.1993-03-24
MOBILIMB T1 TOE CPM UNIT (K925926)Toronto Medical Corp.1993-03-22
ARTROMOT MULTI DIRECTIONAL ANKLE CPM (K924484)Buckman Co., Inc.1993-03-22
THERAPACER 3000 (K925666)Kvm Technologies, Inc.1993-03-09
FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT (K924654)Sutter Corp.1993-02-22
ARTROMOT SB ELBOW ATTACHMENT (K923857)Buckman Co., Inc.1993-02-12
ELBOW CPM ORTHOSIS (K925043)Electrobionics Corp.1993-02-12
POWER PILLOW (K923805)Nova Teknic, Inc.1993-02-12
PARAMED LATERAL FLEXION MACHINE (K923494)Paramed Div1992-11-09
OIC MODEL J4 TMJ CPM (K921348)Lm Product Design, Inc.1992-08-05
DANNIFLEX CPM 2000 (K923217)Buckman Co., Inc.1992-08-03
DANNINFLEX CPM 800 (K923216)Buckman Co., Inc.1992-08-03
AMERICAN MEDICAL MFG. LUMBAR CPM (K922493)American Medical Corp.1992-07-27
JACE KNEE EXTENSION SYSTEM -- MODIFICATION (K922185)Jace Systems, Inc.1992-06-11
ORTHO-PLEX-REHABILITATION SYSTEM (K920686)Plexus Intl., Inc.1992-06-11
CERVICAL PASSIVE MOTION (K921323)Rehabilitative Resources, Inc.1992-06-03
CONTROLLED PASSIVE MOTION MACHINE (K920860)U.S. Mfg. & Management, Inc.1992-04-02
LUMBAR CPM (K920519)Rehabilitative Resources, Inc.1992-03-13
CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY (K920270)Sports Medical Synergy1992-03-02
JACE MODEL W550 WRIST CPM DEVICE (K920380)Jace Systems, Inc.1992-02-11
SUTTER MODEL 10000 LEG CPM DEVICE (K914860)Sutter Corp.1992-01-08
BACK MASTER (K914394)Progressive Electrical Therapeutics1991-11-13
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION (K912537)Thera Kinetics, Inc.1991-08-16
JACE MODEL T300 TOE CPM DEVICE (K913227)Thera Kinetics, Inc.1991-08-16
FMA TRANSLATOR (K912086)Normandie Group, Inc.1991-08-07
EXTEND TRACK UNIT (K904963)Anthony Chiropractic Clinic, Inc.1991-06-28
ROMFLEX (K905718)Paraflex Corp.1991-02-19
DANNIFLEX MODEL 500TM CPM (K904735)Buckman Co., Inc.1991-01-30
ROMFLEX REHAB EQUIP EXTREMITIES UNIT (K910150)Dyna Flex, Intl.1991-01-23
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT (K910151)Dyna Flex, Intl.1991-01-18
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT (K910149)Dyna Flex, Intl.1991-01-18
ATI MEDICAL COMFORT PLUS CPM PAD (K910026)Ati Medical, Inc.1991-01-18
ROMFLEX REHABILITATION EQUIPMENT (K905299)Dyna Flex, Intl.1990-12-31
MOTO-MED RF-II AND PICO (K893924)Holl Meditronics, Inc.1990-11-27
CLUB FOOT CPM MACHINE (K903851)Smith & Nephew Richards, Inc.1990-10-19
JACE MODEL 100 KNEE CPM DEVICE (K903467)Thera Kinetics, Inc.1990-08-10
MODEL 9000 AT ANKLE CPM DEVICE (K902707)Sutter Corp.1990-07-25
CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER (K902452)Berner Assoc., Inc.1990-06-11
MOBILIMB L4 LOWER LIMB CPM UNIT (K900795)Toronto Medical Corp.1990-03-12
MOBILIMB W1 WRIST CPM UNIT (K900466)Toronto Medical Corp.1990-03-12
MOBILIMB J1 TMJ CPM UNIT (K895720)Toronto Medical Corp.1990-01-04
MARK IV HAND, THUMB AND WRIST (CPM) UNIT (K894907)Innovative Medical Engineering, Inc.1989-10-06
ARTROMOT(TM) CPM DEVICES (K895015)Buckman Co., Inc.1989-09-11
MOBILIMB CPM SHOULDER UNIT (K891345)Toronto Medical Corp.1989-04-24
REHABOT-YM (K890838)Imex Health, Inc.1989-03-23
TOTAL KNEE CPM (K885182)Invacare Corp.1989-03-15
SUTTER HOSPITAL CPM (K890607)Sutter Corp.1989-02-27
SUPREME TONING SYSTEMS (K885095)Supreme Toning Systems1989-02-06
PNEUMATIC DORSIFLEXOR (K890200)Medical Flotation Systems, Inc.1989-02-03
PROMO-RIST C.P.M. (K881314)Professional Motion, Inc.1989-01-13
CONVA-LIFT (K882406)Numerical Concepts, Inc.1988-11-30
MOTORIZED PARALLEL BAR, MODEL 110 (K882916)Tri W-G, Inc.1988-07-28
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 (K880865)Invacare Corp.1988-05-02
ANKLE REFLEX TREATMENT UNIT (ARTU) (K873658)Universal Gym Equipment, Inc.1988-04-21
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 (K880092)Invacare Corp.1988-04-11
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