Fst5

FDA UDI

Class II (US FDA UDI)

by Freespira, Inc

Identity

Trade Name: FST5 FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Device Name: Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder. FDA UDI
Model / Reference: 5 FDA UDI
Description: Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder. FDA UDI

Identifiers

Primary DI / UDI-DI: B185FS059370 FDA UDI
510(k) Number: K131586 FDA UDI
K180173 FDA UDI
FDA Product Code: HCC FDA UDI
CCK FDA UDI
GMDN Term: Psychophysiological biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
868.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Psychophysiological biofeedback system

Fst5 by Freespira, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K131586 also covers:

Freespira — Freespira, Inc

K180173 also covers:

Freespira — Freespira, Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Freespira, Inc

Sources (1)

FDA UDI 693bc59a-a55d-410e-bade-2f63ba3155bb 36 fields · synced Jun 8, 2026