Product code LBB— Orthopedic

FDA has cleared 36 devices under product code LBB between 1981 and 2017, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20081 clearance
• 20051 clearance
• 20041 clearance
• 20011 clearance
• 19982 clearances
• 19972 clearances
• 19942 clearances
• 19933 clearances
• 19926 clearances
• 19917 clearances
• 19901 clearance
• 19891 clearance
• 19883 clearances
• 19861 clearance

• Nk Biotechnical Engineering Co.10 clearances
• Chattanooga Group, Inc.4 clearances
• John Chatillon & Sons, Inc.3 clearances
• Greenleaf Medical Systems, Inc.2 clearances
• Tech Dyne Group1 clearance
• Spark Instruments & Academics, Inc.1 clearance
• Saehan Corp.1 clearance
• Orofacial Dynamics1 clearance
• Nk Biotechnical Corp.1 clearance
• Mycron Medical, Inc.1 clearance

• K162412 — Hoggan Scientific® microFET2Hoggan Scientific, LLC·2017-03-09
• K073154 — FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLC·2008-02-14
• K052309 — DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.·2005-09-27
• K042889 — DYNAMOMETER - MODEL FCE AND MODEL MSCAmetek·2004-11-16
• K012492 — KADANCE 2000Kada Research, Inc.·2001-11-02
• K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.·1998-07-17
• K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)Orofacial Dynamics·1998-04-16
• K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)Mekanika, Inc.·1997-02-03
• K964685 — DYNAMOMETERJohn Chatillon & Sons, Inc.·1997-01-27
• K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEMGreenleaf Medical Systems, Inc.·1994-04-15
• K931321 — CSD 200/300/400/500 DYNAMOMETERJohn Chatillon & Sons, Inc.·1994-02-15
• K923964 — NK GRASP SENSOR, MODEL GA001Nk Biotechnical Engineering Co.·1993-05-12
• K923965 — NK GRASP SENSOR, MODEL GA002Nk Biotechnical Engineering Co.·1993-05-12
• K923963 — NK DIGI-GRIP SENSOR, MODEL DGR001Nk Biotechnical Engineering Co.·1993-03-31
• K923262 — DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETERJohn Chatillon & Sons, Inc.·1992-10-27
• K922029 — REMUSK MPEquipement Biomedical Specialise, Inc.·1992-10-06
• K922940 — CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002Exos, Inc.·1992-10-05
• K921268 — NK DYNA-GRIP SENSOR, MODEL DG001Nk Biotechnical Engineering Co.·1992-07-14
• K920183 — TECH DYNE - HP-2000, SKREEN TEST, RMS-200Tech Dyne Group·1992-06-15
• K914436 — CLINICAL HANDMASTER SYSTEM OR CHMSExos Medical Products·1992-01-02
• K914054 — NK GRASP SENSOR, MODEL GR001Nk Biotechnical Engineering Co.·1991-12-09
• K914055 — PINCH SENSOR, MODEL PF001Nk Biotechnical Engineering Co.·1991-12-09
• K914056 — NK PINCH SENSOR, MODEL PF002Nk Biotechnical Engineering Co.·1991-12-09
• K914057 — NK PINCH SENSOR, MODEL PA001Nk Biotechnical Engineering Co.·1991-12-09
• K914059 — NK DEVIATION SENSOR, MODEL DV001Nk Biotechnical Engineering Co.·1991-12-09
• K914058 — NK PINCH SENSOR, MODEL PA002Nk Biotechnical Engineering Co.·1991-12-06
• K912526 — GS-220 HAND IMPAIRMENT EVALUATION SYSTEMJ-Tech, Inc.·1991-09-05
• K901290 — ELECTRO-GONIOMETER DIAGNOSTIC DEVICEChattanooga Group, Inc.·1990-10-01
• K893537 — GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEMGreenleaf Medical Systems, Inc.·1989-10-10
• K884165 — MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYSSpark Instruments & Academics, Inc.·1988-10-26
• K881388 — KIN-COM JRChattanooga Group, Inc.·1988-04-21
• K880464 — DYNATRON IIDynatronics Laser Corp.·1988-03-08
• K860226 — FORCE EVALUATION AND TESTING SYSTEM (FETS)Hoggan Health Industries, Inc.·1986-03-27
• K850697 — DIGITAL GRIP/PINCH STRENGTH METORChattanooga Group, Inc.·1985-05-14
• K812899 — MED-EXChattanooga Group, Inc.·1981-11-06
• K811312 — MYO-METRIC IIMycron Medical, Inc.·1981-06-09