KHX · Platform, Force-Measuring
Physical Medicine · 21 CFR 890.1575 · Class 1
Overview
| Product Code | KHX |
|---|---|
| Device Name | Platform, Force-Measuring |
| Regulation | 21 CFR 890.1575 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A force-measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into analog mechanical or electrical signals. This device is used to determine ground reaction force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951771 | COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM | Sms Technologies, Ltd. | Aug 11, 1995 | SESE |
| K946229 | BALANCE MANAGER | Neurocom International, Inc. | Aug 4, 1995 | SESE |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | Biodex Medical Systems, Inc. | Mar 10, 1995 | SESE |
| K930089 | SMS BALANCE PERFORMANCE MONITOR | Sms Technologies, Ltd. | Jun 8, 1993 | SESE |
| K921340 | FORCE MEASURING PLATFORM | Sra Intl., Inc. | May 26, 1992 | SESE |
| K901069 | COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM | Computerized Functional Testing Corp. | Mar 16, 1990 | SESE |
| K893254 | DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER | Dalphi, Inc. | Jan 2, 1990 | SESE |
| K883198 | BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM | Advanced Mechanical Technology, Inc. | Oct 24, 1988 | SESE |
| K883131 | BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 | Advanced Mechanical Technology, Inc. | Oct 24, 1988 | SESE |
| K883130 | BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 | Advanced Mechanical Technology, Inc. | Oct 24, 1988 | SESE |
| K883129 | BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 | Advanced Mechanical Technology, Inc. | Oct 24, 1988 | SESE |
| K883127 | MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY | Advanced Mechanical Technology, Inc. | Sep 30, 1988 | SESE |
| K863443 | DUAL FORCEPLATE | Neurocom International, Inc. | Sep 17, 1986 | SESE |
| K821255 | ELECTRODYNOGRAM SYSTEM | The Langer Group | Jul 2, 1982 | SESE |
| K820444 | HEART-ALERT | Medical Equipment Devices, Inc. | Mar 12, 1982 | SESE |
Top Applicants
- Advanced Mechanical Technology, Inc. — 5 clearances
- Neurocom International, Inc. — 2 clearances
- Sms Technologies, Ltd. — 2 clearances
- Biodex Medical Systems, Inc. — 1 clearance
- Computerized Functional Testing Corp. — 1 clearance
