MYOTRAC2
FDA 510(k) K915858 · Thought Technology , Ltd.
510(k) numberK915858
Submission
- Device name
- MYOTRAC2
- Applicant
- Thought Technology , Ltd.
Montreal, Quebec, CA - Received
- December 27, 1991
- Decision date
- September 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code HCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233580 | A Breathing System (ABS)HCC · Traditional | Deepwell Dtx, Inc. | 08/01/2024SE |
| K222101 | PrismHCC · Traditional | Graymatters Health , Ltd. | 03/17/2023SE |
| K180173 | FreespiraHCC · Traditional | Palo Alto Health Sciences, Inc. | 08/23/2018SE |
| K163448 | GrindCare SystemHCC · Traditional | Sunstar Suisse S.A. | 09/01/2017SE |
| K151050 | Pacifier Activated Lullaby (PAL®)HCC · Traditional | Power Medical Devices, LLC | 12/22/2015SE |
| K143507 | NFANT Feeding SolutionHCC · Traditional | Nfant Labs, LLC | 09/09/2015SE |
| K131586 | Canary Breathing SystemHCC · Traditional | Palo Alto Health Sciences, Inc. | 12/10/2013SE |
| K122879 | EEGER4 Model 4.3HCC · Traditional | Eeg Software, LLC | 02/06/2013SE |
| K111687 | Emg SystemHCC · Special | Myotronics-Noromed, Inc. | 09/29/2011SE |
| K092675 | GrindcareHCC · Traditional | Medotech A/S | 03/03/2010SE |
More from Medotech A/S
| 510(k) | Device | Decision |
|---|---|---|
| K213197 | MyOnyx SystemIPF · Traditional | 06/17/2022SE |
| K201014 | MyOnyx SystemKPI · Traditional | 01/13/2021SE |
| K053434 | Myotrac Infiniti Electrical StimulatorKPI · Traditional | 03/15/2006SE |
| K053266 | Myotrac InfinitiIPF · Traditional | 12/29/2005SE |
| K925681 | MYOTRAC2D/CSHIR · Traditional | 09/29/1995SE |
| K935213 | IncontrolHIR · Traditional | 05/11/1995SE |
| K932149 | Thought Technology Vaginal & Rectal ElectrodeHIR · Traditional | 05/11/1995SE |
| K915859 | Myotrac/S, Myodac/SHCC · Traditional | 09/09/1992SE |
| K913898 | Myotrac+/S, Myodac+/SHCC · Traditional | 03/26/1992SE |
| K903497 | Flexcomp DSP & ProcompHCC · Traditional | 02/12/1991SE |
Questions and answers
When was MYOTRAC2 cleared by the FDA?
MYOTRAC2 (K915858) received a 510(k) decision of Substantially Equivalent on September 9, 1992, 257 days after the submission was received.
What is the product code of K915858?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.