Boost, Mice, Gamesys.
FDA 510(k) K924416 · Penny and Giles Biometrics , Ltd.
510(k) numberK924416
Submission
- Device name
- Boost, Mice, Gamesys.
- Applicant
- Penny and Giles Biometrics , Ltd.
England, GB - Received
- August 31, 1992
- Decision date
- June 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
| 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 |
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Questions and answers
When was Boost, Mice, Gamesys. cleared by the FDA?
Boost, Mice, Gamesys. (K924416) received a 510(k) decision of Substantially Equivalent on June 15, 1993, 288 days after the submission was received.
What is the product code of K924416?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.