Regulora
Computerized Behavioral Therapy Device For Treating Symptoms
MetaMe Health, Inc.
The following data is part of a premarket notification filed by Metame Health, Inc. with the FDA for Regulora.
Pre-market Notification Details
| Device ID | K211463 |
| 510k Number | K211463 |
| Device Name: | Regulora |
| Classification | Computerized Behavioral Therapy Device For Treating Symptoms |
| Applicant | metaMe Health, Inc. 222 W. Merchandise Mart Plaza - Suite 1230 Chicago, IL 60654 |
| Contact | Tim Rudolphi |
| Correspondent | Nandini Murthy metaMe Health, Inc. 222 W. Merchandise Mart Plaza - Suite 1230 Chicago, IL 60654 |
| Product Code | QMY |
| CFR Regulation Number | 876.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-11-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005970209 | K211463 | 000 |
Trademark Results [Regulora]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REGULORA 87801516 not registered Live/Pending |
Metame Health, Inc. 2018-02-16 |
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