Spine Motion Analyzer with Emg
FDA 510(k) K920256 · Orthopedic Systems, Inc.
510(k) numberK920256
Submission
- Device name
- Spine Motion Analyzer with Emg
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- January 21, 1992
- Decision date
- August 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
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| K945630 | Large Muscle Strength GaugeKQX · Traditional | J-Tech, Inc. | 05/10/1995SE |
| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
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| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | Baltimore Therapeutic Equipment Co. | 06/27/1994SE |
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| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
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Questions and answers
When was Spine Motion Analyzer with Emg cleared by the FDA?
Spine Motion Analyzer with Emg (K920256) received a 510(k) decision of Substantially Equivalent on August 10, 1992, 202 days after the submission was received.
What is the product code of K920256?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.