Arthrometer
The Arthrometer (product code LYH) is a physical medicine measurement device used to objectively quantify joint laxity and range of motion, particularly of the knee, by measuring the displacement of joint structures under controlled applied force. Regulated under 21 CFR 890.1615 and classified as a Class 1 device subject only to general controls, it falls under the Physical Medicine specialty with review by the Neurology (NE) panel. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LYH
- Device Class
- FDA class 1
- Regulation Number
- 890.1615
- Medical Specialty
- Physical Medicine
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943197 | KT1000/S KNEE LIGAMENT ARTHROMETER | Mar 02, 1995 | Substantially Equivalent | Medmetric Corp. |
| K942059 | KT2000 KNEE LIGAMENT ARTHROMETER | Sep 20, 1994 | Substantially Equivalent | Medmetric Corp. |
| K881876 | DYNAMIC CRUCIATE TESTER | Nov 17, 1988 | Substantially Equivalent | Dyonics, Inc. |
| K834462 | GENUCOM | Feb 09, 1984 | Substantially Equivalent | Far Orthopedics, Inc. |
| K812806 | KT-1000 DEVICE | Nov 10, 1981 | Substantially Equivalent | Medmetric Corp. |