The Orthoranger II Electronic Goniometer
FDA 510(k) K884611 · Medical Instruments Technology, Inc.
510(k) numberK884611
Submission
- Device name
- The Orthoranger II Electronic Goniometer
- Applicant
- Medical Instruments Technology, Inc.
Alexandria, VA, US - Received
- November 4, 1988
- Decision date
- January 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
Other 510(k)s with product code KQX
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|---|---|---|---|
| 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 |
More from Baltimore Therapeutic Equipment Co.
| 510(k) | Device | Decision |
|---|---|---|
| K012614 | Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps…JOW · Traditional | 05/01/2002SE |
| K012640 | Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsHRX · Traditional | 02/28/2002SE |
| K012624 | Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited…HRX · Traditional | 11/08/2001SE |
| K012632 | Tourniquet Cuff; Pneumatic TourniquetKCY · Traditional | 10/26/2001SE |
Questions and answers
When was The Orthoranger II Electronic Goniometer cleared by the FDA?
The Orthoranger II Electronic Goniometer (K884611) received a 510(k) decision of Substantially Equivalent on January 31, 1989, 88 days after the submission was received.
What is the product code of K884611?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.