Spinal Touch
FDA 510(k) K961212 · Fasstech
510(k) numberK961212
Submission
- Device name
- Spinal Touch
- Applicant
- Fasstech
Burlington, MA, US - Received
- March 28, 1996
- Decision date
- June 12, 1996
- 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
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|---|---|---|---|
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| K962377 | 3D-SPINEKQX · Traditional | Skill Technologies, Inc. | 09/03/1996SE |
| 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 |
More from Isotechnologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063447 | Insight DiscoveryIKN · Traditional | 08/16/2007SE |
| K033452 | Cwas 1000IKN · Traditional | 11/28/2003SE |
| K023209 | Insight Millennium IIIIKN · Traditional | 10/10/2003SE |
| K011964 | Insight Millennium PlusHCC · Traditional | 09/20/2001SE |
| K011983 | Insight GenesisHCC · Traditional | 08/30/2001SE |
| K990778 | Insight MillenniumHCC · Traditional | 06/03/1999SE |
| K940050 | Focus EmgHCC · Traditional | 02/24/1995SE |
| K925197 | Psi 220 Dual EmgHCC · Traditional | 02/02/1993SE |
Questions and answers
When was Spinal Touch cleared by the FDA?
Spinal Touch (K961212) received a 510(k) decision of Substantially Equivalent on June 12, 1996, 76 days after the submission was received.
What is the product code of K961212?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.