MindMotion(TM) GO
FDA 510(k) K173931 · Mindmaze SA
510(k) numberK173931
Submission
- Device name
- MindMotion(TM) GO
- Applicant
- Mindmaze SA
Lausanne, CH - Received
- December 26, 2017
- Decision date
- May 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXJ – Interactive Rehabilitation Exercise Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
Other 510(k)s with product code LXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192474 | VeraLXJ · Special | Reflexion Health, Inc. | 10/10/2019SE |
| K182333 | VeraLXJ · Traditional | Reflexion Health, Inc. | 04/09/2019SE |
| K180880 | DARI HealthLXJ · Traditional | Scientific Analytics, Inc. | 03/07/2019SE |
| K171547 | Qualisys Clinical SystemLXJ · Traditional | Qualisys AB | 08/02/2018SE |
| K172882 | Uincare HomeLXJ · Traditional | Uincare Corp. | 05/10/2018SE |
| K162748 | MindMotionPROLXJ · Traditional | Mindmaze SA | 04/24/2017SE |
| K163245 | Virtual Occupational Therapy Application (VOTA)LXJ · Traditional | Barron Associates, Inc. | 02/28/2017SE |
| K151955 | YuGo SystemLXJ · Traditional | Biogaming , Ltd. | 02/05/2016SE |
| K150462 | VeraLXJ · Traditional | Reflexion Health, Inc. | 10/30/2015SE |
| K151446 | Recovr Rehabilitation SystemLXJ · Traditional | Recovr,Inc | 09/18/2015SE |
More from Recovr,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K162748 | MindMotionPROLXJ · Traditional | 04/24/2017SE |
Questions and answers
When was MindMotion(TM) GO cleared by the FDA?
MindMotion(TM) GO (K173931) received a 510(k) decision of Substantially Equivalent on May 17, 2018, 142 days after the submission was received.
What is the product code of K173931?
The FDA product code is LXJ – Interactive Rehabilitation Exercise Devices, a Class II (moderate risk) device regulated under 21 CFR 890.5360.