Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart B — Diagnostic Devices](/submissions/OR/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 888.1240](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1240) → LBB — Dynamometer, Ac-Powered # LBB · Dynamometer, Ac-Powered _Orthopedic · 21 CFR 888.1240 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB ## Overview - **Product Code:** LBB - **Device Name:** Dynamometer, Ac-Powered - **Regulation:** [21 CFR 888.1240](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1240) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) ## 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](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K162412.md) | Hoggan Scientific® microFET2™ | Hoggan Scientific, LLC | Mar 9, 2017 | SESE | | [K073154](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K073154.md) | FACTS HAND AND PINCH GRIP COMBO | Global Services Group, LLC | Feb 14, 2008 | SESE | | [K052309](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K052309.md) | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 | Saehan Corp. | Sep 27, 2005 | SESE | | [K042889](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K042889.md) | DYNAMOMETER - MODEL FCE AND MODEL MSC | Ametek | Nov 16, 2004 | SESE | | [K012492](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K012492.md) | KADANCE 2000 | Kada Research, Inc. | Nov 2, 2001 | SESE | | [K981730](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K981730.md) | DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 | Nk Biotechnical Corp. | Jul 17, 1998 | SESE | | [K980363](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K980363.md) | ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) | Orofacial Dynamics | Apr 16, 1998 | SESE | | [K964933](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K964933.md) | MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) | Mekanika, Inc. | Feb 3, 1997 | SESE | | [K964685](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K964685.md) | DYNAMOMETER | John Chatillon & Sons, Inc. | Jan 27, 1997 | SESE | | [K935757](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K935757.md) | GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM | Greenleaf Medical Systems, Inc. | Apr 15, 1994 | SESE | | [K931321](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K931321.md) | CSD 200/300/400/500 DYNAMOMETER | John Chatillon & Sons, Inc. | Feb 15, 1994 | SESE | | [K923965](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K923965.md) | NK GRASP SENSOR, MODEL GA002 | Nk Biotechnical Engineering Co. | May 12, 1993 | SESE | | [K923964](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K923964.md) | NK GRASP SENSOR, MODEL GA001 | Nk Biotechnical Engineering Co. | May 12, 1993 | SESE | | [K923963](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K923963.md) | NK DIGI-GRIP SENSOR, MODEL DGR001 | Nk Biotechnical Engineering Co. | Mar 31, 1993 | SESE | | [K923262](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K923262.md) | DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER | John Chatillon & Sons, Inc. | Oct 27, 1992 | SESE | | [K922029](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K922029.md) | REMUSK MP | Equipement Biomedical Specialise, Inc. | Oct 6, 1992 | SESE | | [K922940](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K922940.md) | CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002 | Exos, Inc. | Oct 5, 1992 | SESE | | [K921268](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K921268.md) | NK DYNA-GRIP SENSOR, MODEL DG001 | Nk Biotechnical Engineering Co. | Jul 14, 1992 | SESE | | [K920183](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K920183.md) | TECH DYNE - HP-2000, SKREEN TEST, RMS-200 | Tech Dyne Group | Jun 15, 1992 | SESE | | [K914436](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB/K914436.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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