Stability System (110V) Model 945-300; Stability System (220V) Model #945-302
FDA 510(k) K942694 · Biodex Medical Systems, Inc.
510(k) numberK942694
Submission
- Device name
- Stability System (110V) Model 945-300; Stability System (220V) Model #945-302
- Applicant
- Biodex Medical Systems, Inc.
Shirley, NY, US - Received
- June 7, 1994
- Decision date
- March 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHX – Platform, Force-Measuring
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.1575
- Specialty
- Physical Medicine
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| K921340 | Force Measuring PlatformKHX · Traditional | Sra Intl., Inc. | 05/26/1992SE |
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| K893254 | Dynamic System Computerized Podiatric AnalyzerKHX · Traditional | Dalphi, Inc. | 01/02/1990SE |
| K883198 | Biovec Biomechanic Force Analysis SystemKHX · Traditional | Advanced Mechanical Technology, Inc. | 10/24/1988SE |
| K883131 | Biomechanics Force Platform #LG6-4-1000 & 2000KHX · Traditional | Advanced Mechanical Technology, Inc. | 10/24/1988SE |
| K883130 | Biomechanics Force Platform/# OR6-5-1000 & 2000KHX · Traditional | Advanced Mechanical Technology, Inc. | 10/24/1988SE |
| K883129 | Biomechanics Force Platform/#Or 6-6-1000 & 2000KHX · Traditional | Advanced Mechanical Technology, Inc. | 10/24/1988SE |
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| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | 11/16/1995SE |
| K950981 | Ultra-Pro Ultrasound Scanning Table Model #056-650IXR · Traditional | 04/03/1995SE |
| K940301 | Compex 2IPF · Traditional | 12/28/1994SN |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | 09/16/1994SE |
| K935061 | Lower Body CyclesBXB · Traditional | 09/16/1994SE |
Questions and answers
When was Stability System (110V) Model 945-300; Stability System (220V) Model #945-302 cleared by the FDA?
Stability System (110V) Model 945-300; Stability System (220V) Model #945-302 (K942694) received a 510(k) decision of Substantially Equivalent on March 10, 1995, 276 days after the submission was received.
What is the product code of K942694?
The FDA product code is KHX – Platform, Force-Measuring, a Class I (low risk) device regulated under 21 CFR 890.1575.