Goniometer, Ac-Powered
FDA product code KQX · Class I (low risk) · 21 CFR 888.1500 · Orthopedic
33510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Orthopedic Systems, Inc. 3
- Nk Biotechnical Engineering Co. 3
- J-Tech, Inc. 2
- Greenleaf Medical Systems, Inc. 2
- Digital Body Systems, Inc. 1
- Orthoscan, Inc. 1
- Isotechnologies, Inc. 1
- Penny and Giles Biometrics , Ltd. 1
- Verimed Holdings, Inc. 1
- Noromed, Inc. 1
- Lucas Sensing Systems, Inc. 1
- Dynatronics Corp. 1
- Physicians Digital Co. 1
- Cairco , Ltd. 1
- Medical Instruments Technology, Inc. 1
- Penny & Giles Blackwood , Ltd. 1
- Cybex 1
- Health Products, Inc. 1
- Prestigeline, Inc. 1
- Smith & Nephew, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011827 | Ortelius 800KQX · Traditional | Orthoscan , Ltd. | 08/28/2001SE |
| K971079 | Interlogics W-Tracker and Wrist Works SoftwareKQX · Traditional | Interlogics, Inc. | 07/09/1997SE |
| K962377 | 3D-SPINEKQX · Traditional | Skill Technologies, Inc. | 09/03/1996SE |
| K961212 | Spinal TouchKQX · Traditional | Fasstech | 06/12/1996SE |
| K954647 | InclinometerKQX · Traditional | J-Tech, Inc. | 10/30/1995SE |
| K943929 | Dataglove and Movement Analysis System (Mas)KQX · Traditional | Greenleaf Medical Systems, Inc. | 05/15/1995SE |
| K945630 | Large Muscle Strength GaugeKQX · Traditional | J-Tech, Inc. | 05/10/1995SE |
| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | Andronic Devices, Ltd. | 11/21/1994SE |
| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | Baltimore Therapeutic Equipment Co. | 06/27/1994SE |
| K933063 | Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional | Isotechnologies, Inc. | 01/27/1994SE |
| K924416 | Boost, Mice, Gamesys.KQX · Traditional | Penny and Giles Biometrics , Ltd. | 06/15/1993SE |
| K922550 | Romas (Range of Motion Assessment System)KQX · Traditional | Verimed Holdings, Inc. | 12/10/1992SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | Orthopedic Systems, Inc. | 08/10/1992SE |
| K920690 | Norotrack 360 InclinometerKQX · Traditional | Noromed, Inc. | 05/20/1992SE |
| K914062 | NK Dexteritly Board, Model BX001KQX · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914061 | NK Range of Motion Sensor, Model RM002KQX · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K914060 | Range of Motion Sensor, Model RM001KQX · Traditional | Nk Biotechnical Engineering Co. | 12/09/1991SE |
| K913079 | 02810-01/02810-02 Orthoranger II/02810-3 Rom 360KQX · Traditional | Lucas Sensing Systems, Inc. | 09/25/1991SE |
| K897178 | Dynatron 360 Range of Motion Testing DeviceKQX · Traditional | Dynatronics Corp. | 04/18/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | Orthopedic Systems, Inc. | 01/19/1990SE |
| K893903 | Kronamax KubeKQX · Traditional | Physicians Digital Co. | 11/29/1989SE |
| K893455 | The Handscan SystemKQX · Traditional | Digital Body Systems, Inc. | 08/30/1989SE |
| K884723 | (Dataglove) Hand Impairment Evaluation SystemKQX · Traditional | Greenleaf Medical Systems, Inc. | 02/08/1989SE |
| K884611 | The Orthoranger II Electronic GoniometerKQX · Traditional | Medical Instruments Technology, Inc. | 01/31/1989SE |
| K884003 | Goniometer and Biomedical Recorder SystemKQX · Traditional | Penny & Giles Blackwood , Ltd. | 12/19/1988SE |
| K873599 | Edi 320KQX · Traditional | Cybex | 10/16/1987SE |
| K862128 | Digital Electronic Myo-Graph (Muscle Analyzer)KQX · Traditional | Health Products, Inc. | 07/11/1986SE |
| K852390 | CMT 1000KQX · Traditional | Prestigeline, Inc. | 07/19/1985SE |
| K832991 | Hypal Adhesive TapeKQX · Traditional | Smith & Nephew, Inc. | 01/30/1984SE |
| K831040 | Lamoreux-Osi ElectrogoniometerKQX · Traditional | Orthopedic Systems, Inc. | 07/12/1983SE |
| K812908 | Electro-GoniometerKQX · Traditional | Chattanooga Group, Inc. | 11/24/1981SE |
| K810640 | Polarised Light GroniometerKQX · Traditional | Cairco , Ltd. | 04/17/1981SE |