Atlas FDA

EaseVRx

FDA 510(k) clearance DEN210014 · decided 2021-11-16

Clearance details

K-number
DEN210014
Device name
EaseVRx
Applicant
Appliedvr, Inc.
Decision
Unknown
Date received
2021-03-30
Decision date
2021-11-16
Days to decision
231 days
Clearance type
Direct
Product code
QRA
Device class
2
Regulation number
890.5800
Medical specialty
Neurology
Advisory committee
Neurology
Location
Van Nuys, 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.

RecordFirmDate
VRNT (K254004)Cognifisense, Inc.2026-04-10
RelieVRx (Pico G3) (K251519)Appliedvr2025-08-13
RelieVRx (K243417)Appliedvr2024-12-04
VRNT (K230814)Cognifisense, Inc.2023-10-31
Smileyscope System (Therapy Mode) (K230825)Smileyscope Holding, Inc.2023-09-25

Recalls involving this device

No recalls on record reference this clearance.