LBB · Dynamometer, Ac-Powered
Orthopedic · 21 CFR 888.1240 · Class 2
Overview
| Product Code | LBB |
|---|---|
| Device Name | Dynamometer, Ac-Powered |
| Regulation | 21 CFR 888.1240 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162412 | Hoggan Scientific® microFET2 | Hoggan Scientific, LLC | Mar 9, 2017 | SESE |
| K073154 | FACTS HAND AND PINCH GRIP COMBO | Global Services Group, LLC | Feb 14, 2008 | SESE |
| K052309 | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 | Saehan Corp. | Sep 27, 2005 | SESE |
| K042889 | DYNAMOMETER - MODEL FCE AND MODEL MSC | Ametek | Nov 16, 2004 | SESE |
| K012492 | KADANCE 2000 | Kada Research, Inc. | Nov 2, 2001 | SESE |
| K981730 | DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 | Nk Biotechnical Corp. | Jul 17, 1998 | SESE |
| K980363 | ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) | Orofacial Dynamics | Apr 16, 1998 | SESE |
| K964933 | MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) | Mekanika, Inc. | Feb 3, 1997 | SESE |
| K964685 | DYNAMOMETER | John Chatillon & Sons, Inc. | Jan 27, 1997 | SESE |
| K935757 | GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM | Greenleaf Medical Systems, Inc. | Apr 15, 1994 | SESE |
| K931321 | CSD 200/300/400/500 DYNAMOMETER | John Chatillon & Sons, Inc. | Feb 15, 1994 | SESE |
| K923965 | NK GRASP SENSOR, MODEL GA002 | Nk Biotechnical Engineering Co. | May 12, 1993 | SESE |
| K923964 | NK GRASP SENSOR, MODEL GA001 | Nk Biotechnical Engineering Co. | May 12, 1993 | SESE |
| K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | Nk Biotechnical Engineering Co. | Mar 31, 1993 | SESE |
| K923262 | DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER | John Chatillon & Sons, Inc. | Oct 27, 1992 | SESE |
| K922029 | REMUSK MP | Equipement Biomedical Specialise, Inc. | Oct 6, 1992 | SESE |
| K922940 | CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002 | Exos, Inc. | Oct 5, 1992 | SESE |
| K921268 | NK DYNA-GRIP SENSOR, MODEL DG001 | Nk Biotechnical Engineering Co. | Jul 14, 1992 | SESE |
| K920183 | TECH DYNE - HP-2000, SKREEN TEST, RMS-200 | Tech Dyne Group | Jun 15, 1992 | SESE |
| K914436 | CLINICAL HANDMASTER SYSTEM OR CHMS | Exos Medical Products | Jan 2, 1992 | SESE |
Top Applicants
- 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 Group — 1 clearance
