Atlas FDA

KQX

33 FDA 510(k) clearances · Product code

96 daysmedian time to decision
272 days90th percentile
33clearances measured

FDA profile

Official device name
Goniometer, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 888.1500
Medical specialty
Orthopedic
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RecordFirmDate
ORTELIUS 800 (K011827)Orthoscan , Ltd.2001-08-28
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (K971079)Interlogics, Inc.1997-07-09
3D-SPINE (K962377)Skill Technologies, Inc.1996-09-03
SPINAL TOUCH (K961212)Fasstech1996-06-12
INCLINOMETER (K954647)J-Tech, Inc.1995-10-30
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (K943929)Greenleaf Medical Systems, Inc.1995-05-15
LARGE MUSCLE STRENGTH GAUGE (K945630)J-Tech, Inc.1995-05-10
SAUNDERS ELECTRONIC INCLINOMETER (K943898)The Saunders Group1994-11-28
INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812)Andronic Devices, Ltd.1994-11-21
THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (K925225)Baltimore Therapeutic Equipment Co.1994-06-27
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (K933063)Isotechnologies, Inc.1994-01-27
BOOST, MICE, GAMESYS. (K924416)Penny and Giles Biometrics , Ltd.1993-06-15
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) (K922550)Verimed Holdings, Inc.1992-12-10
SPINE MOTION ANALYZER WITH EMG (K920256)Orthopedic Systems, Inc.1992-08-10
NOROTRACK 360 INCLINOMETER (K920690)Noromed, Inc.1992-05-20
RANGE OF MOTION SENSOR, MODEL RM001 (K914060)Nk Biotechnical Engineering Co.1991-12-09
NK RANGE OF MOTION SENSOR, MODEL RM002 (K914061)Nk Biotechnical Engineering Co.1991-12-09
NK DEXTERITLY BOARD, MODEL BX001 (K914062)Nk Biotechnical Engineering Co.1991-12-09
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 (K913079)Lucas Sensing Systems, Inc.1991-09-25
DYNATRON 360 RANGE OF MOTION TESTING DEVICE (K897178)Dynatronics Corp.1990-04-18
COMPREHENSIVE SPINE MOTION ANALYZER (K894283)Orthopedic Systems, Inc.1990-01-19
KRONAMAX KUBE (K893903)Physicians Digital Co.1989-11-29
THE HANDSCAN SYSTEM (K893455)Digital Body Systems, Inc.1989-08-30
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (K884723)Greenleaf Medical Systems, Inc.1989-02-08
THE ORTHORANGER II ELECTRONIC GONIOMETER (K884611)Medical Instruments Technology, Inc.1989-01-31
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM (K884003)Penny & Giles Blackwood , Ltd.1988-12-19
EDI 320 (K873599)Cybex1987-10-16
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) (K862128)Health Products, Inc.1986-07-11
CMT 1000 (K852390)Prestigeline, Inc.1985-07-19
HYPAL ADHESIVE TAPE (K832991)Smith & Nephew, Inc.1984-01-30
LAMOREUX-OSI ELECTROGONIOMETER (K831040)Orthopedic Systems, Inc.1983-07-12
ELECTRO-GONIOMETER (K812908)Chattanooga Group, Inc.1981-11-24
POLARISED LIGHT GRONIOMETER (K810640)Cairco , Ltd.1981-04-17

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Every clearance here is in the API, with alerts when new ones post.