510(k) K192474
- Device
- VERA
- Applicant
- Reflexion Health, Inc.
- 510(k) number
- K192474
- Product code
- LXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-10
- Date received
- 2019-09-10
- Regulation
- 890.5360
- Classification name
- System, Optical Position/movement Recording
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Walter Cordiglia
- Address
- 225 Broadway Suite 300 San Diego CA US 62101 62101
FDA Registration Numbers#
- 3010070342
- 3020018
- 8021839
- 3015443141
- 3011197286
- 3005998761
- 3013517146
- 1000377231
- 3015786441
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182333 | Vera | Reflexion Health, Inc. | 2019-04-09 |
| K180880 | DARI Health | Scientific Analytics, Inc. | 2019-03-07 |
| K171547 | Qualisys Clinical System | Qualisys AB | 2018-08-02 |
| K173931 | MindMotion(TM) GO | Mindmaze SA | 2018-05-17 |
| K172882 | UINCARE HOME | Uincare Corp. | 2018-05-10 |
| K162748 | MindMotionPRO | Mindmaze SA | 2017-04-24 |
| K163245 | Virtual Occupational Therapy Application (VOTA) | Barron Associates, Inc. | 2017-02-28 |
| K151955 | YuGo System | Biogaming , Ltd. | 2016-02-05 |
| K150462 | Vera | Reflexion Health, Inc. | 2015-10-30 |
| K151446 | Recovr Rehabilitation System | Recovr,Inc | 2015-09-18 |
| K143034 | Jintronix | Jintronix, Inc. | 2015-04-22 |
| K131660 | SMART (SMART-D, SMART-DX) | Bts S.P.A. | 2014-04-17 |
| K130847 | JINTRONIX REHABILITATION SYSTEM (JRS) | Jintronix, Inc. | 2014-02-28 |
| K091000 | KNEEKG | Emovi | 2009-10-26 |
| K033514 | CODA CX1 MOTION ANALYSIS SYSTEM | Charnwood Dynamics , Ltd. | 2004-01-06 |
Legacy Summary#
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FDA Review#
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