Freespira
Device, Biofeedback
Palo Alto Health Sciences, Inc.
The following data is part of a premarket notification filed by Palo Alto Health Sciences, Inc. with the FDA for Freespira.
Pre-market Notification Details
| Device ID | K180173 |
| 510k Number | K180173 |
| Device Name: | Freespira |
| Classification | Device, Biofeedback |
| Applicant | Palo Alto Health Sciences, Inc. 12020 113th Ave NE, Building C, Suite 215 Kirkland, WA 98034 |
| Contact | Simon Thomas |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
Trademark Results [Freespira]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESPIRA 86419307 4868104 Live/Registered |
Palo Alto Health Sciences, Inc. 2014-10-09 |
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