Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart B — Physical Medicine Diagnostic Devices](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices) → [21 CFR 890.1925](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1925) → IKK — System, Isokinetic Testing And Evaluation # IKK · System, Isokinetic Testing And Evaluation _Physical Medicine · 21 CFR 890.1925 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK ## Overview - **Product Code:** IKK - **Device Name:** System, Isokinetic Testing And Evaluation - **Regulation:** [21 CFR 890.1925](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1925) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints. ## 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 § 890.9. ## 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 § 890.9. ## Recent Cleared Devices (20 of 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K123746](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K123746.md) | AMES THERAPY DEVICE | Ames Technology, Inc. | May 24, 2013 | SESE | | [K952090](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K952090.md) | HUMAC SYSTEM | Computer Sports Medicine, Inc. | Dec 11, 1995 | SESE | | [K951770](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K951770.md) | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | Biodex Medical Systems, Inc. | Nov 16, 1995 | SESE | | [K951916](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K951916.md) | CC RIDER, MODEL ME180 | Mettler Electronics Corp. | Oct 4, 1995 | SESE | | [K950095](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K950095.md) | CYBEX 770 | Cybex | Jun 21, 1995 | SESE | | [K942229](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K942229.md) | MOTIVATOR FTR 2000 | Hogan & Hartson | Feb 27, 1995 | SESE | | [K944732](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K944732.md) | DEXTER ISOKINETIC | Cedaron Medical, Inc. | Feb 3, 1995 | SESE | | [K924414](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K924414.md) | THE BTE DYNAMIC LIFT | Baltimore Therapeutic Equipment Co. | Feb 12, 1993 | SESE | | [K923350](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K923350.md) | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | Jul 23, 1992 | SESE | | [K922772](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K922772.md) | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | Jul 13, 1992 | SESE | | [K922092](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K922092.md) | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | May 26, 1992 | SESE | | [K915144](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K915144.md) | DEXTER HAND EVALUATION AND THERAPY SYSTEM | Cedars Medical Center | Apr 2, 1992 | SESE | | [K915846](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K915846.md) | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | Jan 13, 1992 | SESE | | [K915648](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K915648.md) | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | Jan 9, 1992 | SESE | | [K913021](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K913021.md) | BIODEX,MODEL B-2000 | Biodex Corp. | Oct 3, 1991 | SESE | | [K913020](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K913020.md) | BIODEX SYSTEM 2,MODEL S2-S | Biodex Corp. | Oct 3, 1991 | SESE | | [K911805](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K911805.md) | KIN-COM ASYMMETRICAL BACK SYSTEM | Chattanooga Group, Inc. | Jul 3, 1991 | SESE | | [K911666](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K911666.md) | MEDX MACHINE | Medx Corp. | Jul 3, 1991 | SESE | | [K905525](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K905525.md) | CYBEX 6000 | Cybex | Feb 14, 1991 | SESE | | [K904898](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K904898.md) | TORQUE FRAME QTF1000 | Medmetric Corp. | Nov 28, 1990 | SESE | ## Top Applicants - Biodex Corp. — 7 clearances - Cybex — 7 clearances - Loredan Biomedical, Inc. — 7 clearances - Kent Design & Manufacturing, Inc. — 6 clearances - Biodan Medical Systems, Ltd. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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