Dynamometer, Ac-Powered
FDA product code LBB · Class II (moderate risk) · 21 CFR 888.1240 · Orthopedic
36510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Nk Biotechnical Engineering Co. 10
- Chattanooga Group, Inc. 4
- John Chatillon & Sons, Inc. 3
- Greenleaf Medical Systems, Inc. 2
- Hoggan Scientific, LLC 1
- Mycron Medical, Inc. 1
- Global Services Group, LLC 1
- Saehan Corp. 1
- Ametek, Inc. 1
- Kada Research, Inc. 1
- Nk Biotechnical Corp. 1
- Orofacial Dynamics 1
- Mekanika, Inc. 1
- Equipement Biomedical Specialise, Inc. 1
- Exos, Inc. 1
- Tech Dyne Group 1
- Exos Medical Products 1
- J-Tech, Inc. 1
- Spark Instruments & Academics, Inc. 1
- Dynatronics Laser Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162412 | Hoggan Scientific® microFET2LBB · Traditional | Hoggan Scientific, LLC | 03/09/2017SE |
| K073154 | Facts Hand and Pinch Grip ComboLBB · Traditional | Global Services Group, LLC | 02/14/2008SE |
| K052309 | Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006LBB · Traditional | Saehan Corp. | 09/27/2005SE |
| K042889 | Dynamometer - Model Fce and Model MSCLBB · Traditional | Ametek | 11/16/2004SE |
| K012492 | Kadance 2000LBB · Traditional | Kada Research, Inc. | 11/02/2001SE |
| K981730 | Digit-Grip with LCD, Model Number DGR 002LBB · Traditional | Nk Biotechnical Corp. | 07/17/1998SE |
| K980363 | Oro-Facial Myographic Measurement Instrument (Ommi)LBB · Traditional | Orofacial Dynamics | 04/16/1998SE |
| K964933 | Mekanika's Spinal Stiffness Gauge (SSG)LBB · Traditional | Mekanika, Inc. | 02/03/1997SE |
| K964685 | DynamometerLBB · Traditional | John Chatillon & Sons, Inc. | 01/27/1997SE |
| K935757 | Greenleaf Eval System/ Greenleaf SolosystemLBB · Traditional | Greenleaf Medical Systems, Inc. | 04/15/1994SE |
| K931321 | CSD 200/300/400/500 DynamometerLBB · Traditional | John Chatillon & Sons, Inc. | 02/15/1994SE |
| K923965 | NK Grasp Sensor, Model GA002LBB · Traditional | Nk Biotechnical Engineering Co. | 05/12/1993SE |
| K923964 | NK Grasp Sensor, Model GA001LBB · Traditional | Nk Biotechnical Engineering Co. | 05/12/1993SE |
| K923963 | NK Digi-Grip Sensor, Model DGR001LBB · Traditional | Nk Biotechnical Engineering Co. | 03/31/1993SE |
| K923262 | DMG100 and 500 Isometric Strength DynamometerLBB · Traditional | John Chatillon & Sons, Inc. | 10/27/1992SE |
| K922029 | Remusk MPLBB · Traditional | Equipement Biomedical Specialise, Inc. | 10/06/1992SE |
| K922940 | Clincal Hand Master System Model # EXH9000-002LBB · Traditional | Exos, Inc. | 10/05/1992SE |
| K921268 | NK Dyna-Grip Sensor, Model DG001LBB · Traditional | Nk Biotechnical Engineering Co. | 07/14/1992SE |
| K920183 | Tech Dyne - HP-2000, Skreen Test, RMS-200LBB · Traditional | Tech Dyne Group | 06/15/1992SE |
| K914436 | Clinical Handmaster System or CHMSLBB · Traditional | Exos Medical Products | 01/02/1992SE |
| K914059 | NK Deviation Sensor, Model DV001LBB · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914057 | NK Pinch Sensor, Model PA001LBB · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914056 | NK Pinch Sensor, Model PF002LBB · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914055 | Pinch Sensor, Model PF001LBB · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914054 | NK Grasp Sensor, Model GR001LBB · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914058 | NK Pinch Sensor, Model PA002LBB · Traditional | Nk Biotechnical Engineering Co. | 12/06/1991SE |
| K912526 | GS-220 Hand Impairment Evaluation SystemLBB · Traditional | J-Tech, Inc. | 09/05/1991SE |
| K901290 | Electro-Goniometer Diagnostic DeviceLBB · Traditional | Chattanooga Group, Inc. | 10/01/1990SE |
| K893537 | Greenleaf Hand Impairment Evaluation SystemLBB · Traditional | Greenleaf Medical Systems, Inc. | 10/10/1989SE |
| K884165 | Muscle Examination & Exercise Dosimeter (Meed) SysLBB · Traditional | Spark Instruments & Academics, Inc. | 10/26/1988SE |
| K881388 | Kin-Com JRLBB · Traditional | Chattanooga Group, Inc. | 04/21/1988SE |
| K880464 | Dynatron IILBB · Traditional | Dynatronics Laser Corp. | 03/08/1988SE |
| K860226 | Force Evaluation and Testing System (Fets)LBB · Traditional | Hoggan Health Industries, Inc. | 03/27/1986SE |
| K850697 | Digital Grip/Pinch Strength MetorLBB · Traditional | Chattanooga Group, Inc. | 05/14/1985SE |
| K812899 | Med-ExLBB · Traditional | Chattanooga Group, Inc. | 11/06/1981SE |
| K811312 | Myo-Metric IILBB · Traditional | Mycron Medical, Inc. | 06/09/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0386-2022 Class II | activforce 2 package labeling: Model: Activ5-M R 201-200563Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential… | Activbody, Inc. | 11/30/2021Open, Classified |
| Z-0385-2022 Class II | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5…Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential… | Activbody, Inc. | 11/30/2021Open, Classified |