Product code KHX
- Device name
- Platform, Force-Measuring
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.1575
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951771 | COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM | Sms Technologies, Ltd. | 1995-08-11 |
| K946229 | BALANCE MANAGER | Neurocom International, Inc. | 1995-08-04 |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | Biodex Medical Systems, Inc. | 1995-03-10 |
| K930089 | SMS BALANCE PERFORMANCE MONITOR | Sms Technologies, Ltd. | 1993-06-08 |
| K921340 | FORCE MEASURING PLATFORM | Sra Intl., Inc. | 1992-05-26 |
| K901069 | COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM | Computerized Functional Testing Corp. | 1990-03-16 |
| K893254 | DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER | Dalphi, Inc. | 1990-01-02 |
| K883129 | BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 | Advanced Mechanical Technology, Inc. | 1988-10-24 |
| K883130 | BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 | Advanced Mechanical Technology, Inc. | 1988-10-24 |
| K883131 | BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 | Advanced Mechanical Technology, Inc. | 1988-10-24 |
| K883198 | BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM | Advanced Mechanical Technology, Inc. | 1988-10-24 |
| K883127 | MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY | Advanced Mechanical Technology, Inc. | 1988-09-30 |
| K863443 | DUAL FORCEPLATE | Neurocom International, Inc. | 1986-09-17 |
| K821255 | ELECTRODYNOGRAM SYSTEM | The Langer Group | 1982-07-02 |
| K820444 | HEART-ALERT | Medical Equipment Devices, Inc. | 1982-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08908024776005 | EQUIPOISE | EQUIDOR MEDTECH LLP | 2025-02-19 |
| 03770011995387 | KForce Plates | KINVENT BIOMECANIQUE | 2024-01-03 |
| 03770011995417 | KForce Deltas | KINVENT BIOMECANIQUE | 2024-01-03 |
| 03770011995608 | KForce Deltas XL | KINVENT BIOMECANIQUE | 2024-01-03 |
| 00008600088282 | Koresway | Diversified Healthcare Development, LLC | 2023-08-22 |
| B915015430301 | FDM-3 System | zebris MEDICAL GmbH | 2023-08-11 |
| B915012430050 | FDM-SX | zebris MEDICAL GmbH | 2023-08-11 |
| B915012430100 | FDM-S | zebris MEDICAL GmbH | 2023-08-11 |
| B915012430150 | FDM-1.5 | zebris MEDICAL GmbH | 2023-08-11 |
| B915012430200 | FDM-2 | zebris MEDICAL GmbH | 2023-08-11 |
| B915012430300 | FDM-3 | zebris MEDICAL GmbH | 2023-08-11 |
| B915015430051 | FDM-SX System | zebris MEDICAL GmbH | 2023-08-11 |
| B915015430101 | FDM-S System | zebris MEDICAL GmbH | 2023-08-11 |
| B915015430151 | FDM-1.5 System | zebris MEDICAL GmbH | 2023-08-11 |
| B915015430201 | FDM-2 System | zebris MEDICAL GmbH | 2023-08-11 |
| 00718175004302 | VibroTactile | SPORT MEDICAL TECHNOLOGY INC. | 2023-07-19 |
| B435MT07 | MotionTrak | WESTERN SYSTEMS RESEARCH INC. | 2023-06-27 |
| 04260242060132 | DIERS pedogait | DIERS International GmbH | 2023-06-02 |
| 24900070945129 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 24900070937421 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 04900070942322 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 24900070945112 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 24900070937414 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 04900070930664 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 24900070945211 | MOLDCARE RI II | ALCARE CO., LTD. | 2023-04-16 |
| 00860010129104 | BTrackS Balance Plate | Balance Tracking Systems Incorporated | 2023-03-30 |
| 00860010129111 | Assess Balance | Balance Tracking Systems Incorporated | 2023-03-30 |
| 00850017250116 | Bertec Head Mounted Display System (HMD) | BERTEC CORPORATION | 2023-02-08 |
| 24900070938220 | MOLDCARE RI II | ALCARE CO., LTD. | 2022-11-25 |
| B702P32C0 | CAPS | VESTIBULAR TECHNOLOGIES, LLC | 2019-12-01 |