Atlas FDA

LBB

36 FDA 510(k) clearances · Product code

90 daysmedian time to decision
236 days90th percentile
36clearances measured

FDA profile

Official device name
Dynamometer, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1240
Medical specialty
Orthopedic
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RecordFirmDate
Hoggan Scientific® microFET2™ (K162412)Hoggan Scientific, LLC2017-03-09
FACTS HAND AND PINCH GRIP COMBO (K073154)Global Services Group, LLC2008-02-14
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (K052309)Saehan Corp.2005-09-27
DYNAMOMETER - MODEL FCE AND MODEL MSC (K042889)Ametek2004-11-16
KADANCE 2000 (K012492)Kada Research, Inc.2001-11-02
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (K981730)Nk Biotechnical Corp.1998-07-17
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (K980363)Orofacial Dynamics1998-04-16
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (K964933)Mekanika, Inc.1997-02-03
DYNAMOMETER (K964685)John Chatillon & Sons, Inc.1997-01-27
GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (K935757)Greenleaf Medical Systems, Inc.1994-04-15
CSD 200/300/400/500 DYNAMOMETER (K931321)John Chatillon & Sons, Inc.1994-02-15
NK GRASP SENSOR, MODEL GA002 (K923965)Nk Biotechnical Engineering Co.1993-05-12
NK GRASP SENSOR, MODEL GA001 (K923964)Nk Biotechnical Engineering Co.1993-05-12
NK DIGI-GRIP SENSOR, MODEL DGR001 (K923963)Nk Biotechnical Engineering Co.1993-03-31
DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER (K923262)John Chatillon & Sons, Inc.1992-10-27
REMUSK MP (K922029)Equipement Biomedical Specialise, Inc.1992-10-06
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002 (K922940)Exos, Inc.1992-10-05
NK DYNA-GRIP SENSOR, MODEL DG001 (K921268)Nk Biotechnical Engineering Co.1992-07-14
TECH DYNE - HP-2000, SKREEN TEST, RMS-200 (K920183)Tech Dyne Group1992-06-15
CLINICAL HANDMASTER SYSTEM OR CHMS (K914436)Exos Medical Products1992-01-02
NK PINCH SENSOR, MODEL PA001 (K914057)Nk Biotechnical Engineering Co.1991-12-09
PINCH SENSOR, MODEL PF001 (K914055)Nk Biotechnical Engineering Co.1991-12-09
NK GRASP SENSOR, MODEL GR001 (K914054)Nk Biotechnical Engineering Co.1991-12-09
NK DEVIATION SENSOR, MODEL DV001 (K914059)Nk Biotechnical Engineering Co.1991-12-09
NK PINCH SENSOR, MODEL PF002 (K914056)Nk Biotechnical Engineering Co.1991-12-09
NK PINCH SENSOR, MODEL PA002 (K914058)Nk Biotechnical Engineering Co.1991-12-06
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (K912526)J-Tech, Inc.1991-09-05
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE (K901290)Chattanooga Group, Inc.1990-10-01
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM (K893537)Greenleaf Medical Systems, Inc.1989-10-10
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS (K884165)Spark Instruments & Academics, Inc.1988-10-26
KIN-COM JR (K881388)Chattanooga Group, Inc.1988-04-21
DYNATRON II (K880464)Dynatronics Laser Corp.1988-03-08
FORCE EVALUATION AND TESTING SYSTEM (FETS) (K860226)Hoggan Health Industries, Inc.1986-03-27
DIGITAL GRIP/PINCH STRENGTH METOR (K850697)Chattanooga Group, Inc.1985-05-14
MED-EX (K812899)Chattanooga Group, Inc.1981-11-06
MYO-METRIC II (K811312)Mycron Medical, Inc.1981-06-09

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