Dynamic System Computerized Podiatric Analyzer
FDA 510(k) K893254 · Dalphi, Inc.
510(k) numberK893254
Submission
- Device name
- Dynamic System Computerized Podiatric Analyzer
- Applicant
- Dalphi, Inc.
Washington, DC, US - Received
- April 28, 1989
- Decision date
- January 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHX – Platform, Force-Measuring
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.1575
- Specialty
- Physical Medicine
Other 510(k)s with product code KHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951771 | Community Balance Performance Monitor or Community BPMKHX · Traditional | Sms Technologies, Ltd. | 08/11/1995SE |
| K946229 | Balance ManagerKHX · Traditional | Neurocom International, Inc. | 08/04/1995SE |
| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302KHX · Traditional | Biodex Medical Systems, Inc. | 03/10/1995SE |
| K930089 | SMS Balance Performance MonitorKHX · Traditional | Sms Technologies, Ltd. | 06/08/1993SE |
| K921340 | Force Measuring PlatformKHX · Traditional | Sra Intl., Inc. | 05/26/1992SE |
| K901069 | Computerized Functional Testing Gait SystemKHX · Traditional | Computerized Functional Testing Corp. | 03/16/1990SE |
| 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 |
Questions and answers
When was Dynamic System Computerized Podiatric Analyzer cleared by the FDA?
Dynamic System Computerized Podiatric Analyzer (K893254) received a 510(k) decision of Substantially Equivalent on January 2, 1990, 249 days after the submission was received.
What is the product code of K893254?
The FDA product code is KHX – Platform, Force-Measuring, a Class I (low risk) device regulated under 21 CFR 890.1575.