Vera
FDA 510(k) clearance K150462 · decided 2015-10-30
Clearance details
- K-number
- K150462
- Device name
- Vera
- Applicant
- Reflexion Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-23
- Decision date
- 2015-10-30
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- LXJ
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERA (K192474) | Reflexion Health, Inc. | 2019-10-10 |
| Vera (K182333) | Reflexion Health, Inc. | 2019-04-09 |
| DARI Health (K180880) | Scientific Analytics, Inc. | 2019-03-07 |
| Qualisys Clinical System (K171547) | Qualisys AB | 2018-08-02 |
| MindMotion(TM) GO (K173931) | Mindmaze SA | 2018-05-17 |
| UINCARE HOME (K172882) | Uincare Corp. | 2018-05-10 |
| MindMotionPRO (K162748) | Mindmaze SA | 2017-04-24 |
| Virtual Occupational Therapy Application (VOTA) (K163245) | Barron Associates, Inc. | 2017-02-28 |
| YuGo System (K151955) | Biogaming , Ltd. | 2016-02-05 |
| Recovr Rehabilitation System (K151446) | Recovr,Inc | 2015-09-18 |
| Jintronix (K143034) | Jintronix, Inc. | 2015-04-22 |
| SMART (SMART-D, SMART-DX) (K131660) | Bts S.P.A. | 2014-04-17 |
Recalls involving this device
No recalls on record reference this clearance.