Freespira 04275

GUDID B185SM40500

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.

Freespira, Inc.

Psychophysiological biofeedback system

• Primary Device ID: B185SM40500
• NIH Device Record Key: 23f736e8-75aa-4e1c-b78a-bdc261142144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freespira
• Version Model Number: 3
• Catalog Number: 04275
• Company DUNS: 068023986
• Company Name: Freespira, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-735-8995
• Email: par@freespira.com
• Phone: 800-735-8995
• Email: par@freespira.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B185SM40500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131586

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25