BREATHE FIT

K963326 · Cambridge Assoc. · LWF · Feb 12, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K963326
• Device Name: BREATHE FIT
• Applicant: Cambridge Assoc.
• Product Code: LWF · Ear, Nose, Throat
• Decision Date: Feb 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3900
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Breathe Fit™ is a drug free, non-prescription adhesive device that mechanically improves nasal breathing by opening the nasal passages.

Device Story

Adhesive nasal strip; mechanically lifts nasal passages to reduce airway resistance; improves nasal airflow; non-prescription; patient self-applied; drug-free; provides relief for nasal congestion or breathing difficulties.

Technological Characteristics

Adhesive strip; mechanical nasal dilator; non-invasive; drug-free.

Indications for Use

Indicated for individuals seeking to improve nasal airflow and facilitate freer breathing; non-prescription use.

Regulatory Classification

Identification

A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

Predicate Devices

• Breathe Right (CNS, Inc.)

Submission Summary (Full Text)

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510K Submission for BREATHE FIT™ Cambridge Associates, Inc. K963326
FEB 12 1997
6

# 510K SUMMARY

**Product Name:** BREATHE FIT™

**Sponsor's Name:**
Cambridge Associates
P.O. Box 2048
Fort Lee, NJ 07024

## SUBSTANTIAL EQUIVALENCE

Breathe Fit™ is substantially equivalent to another commercially available product which uses similar methodology for improving nasal air flow to allow freer breathing.

**Manufacturer:** CNS, Inc.
**Product:** Breathe Right -
A drug free, non-prescription adhesive device that mechanically improves nasal breathing by opening the nasal passages.