FDA COMPLIANCE

MEDICAL DEVICE STATEMENT

Last Updated: April 10, 2025

Medical Device Classification

Apex Stethoscopes are classified as Class I medical devices under the United States Food and Drug Administration (FDA) regulations. As the importer and distributor of these devices, Apex Bioacoustics Inc complies with all applicable FDA guidelines for the importation and distribution of Class I medical devices.

Regulatory Compliance

FDA Registration and Listing

Apex Bioacoustics Inc is properly registered with the FDA as an importer and distributor of medical devices. Our manufacturer is appropriately registered and listed with the FDA as confirmed by our regulatory representatives, Smith and Associates (FDAconsultants.com). Our stethoscopes are listed in the FDA database as required by regulation.

Quality System Regulation

Class I devices like stethoscopes are generally exempt from most provisions of the Quality System Regulation (21 CFR Part 820), with the exception of requirements for complaint handling and recordkeeping. However, we voluntarily implement internal quality controls aligned with current Good Manufacturing Practices (cGMP) to ensure safety and performance.

Device Identification and Labeling

Apex Stethoscopes comply with applicable FDA requirements for device identification and labeling, including Unique Device Identifier (UDI) regulations for Class I devices.

Medical Device Reporting

We comply with the FDA's Medical Device Reporting (MDR) regulations, which require manufacturers to report certain device-related adverse events and product problems to the FDA.

Import Requirements

All Apex Stethoscopes imported into the United States comply with FDA import requirements for medical devices, including proper labeling, registration, and documentation. We work closely with our manufacturer to ensure that all products meet applicable regulatory standards before distribution.

Jurisdictional Scope

This statement reflects our compliance with U.S. FDA regulations. If you are purchasing from a country outside the United States, please ensure compliance with local regulations or consult local authorities regarding medical device usage.

Intended Use Statement

Apex Stethoscopes are specifically designed and intended for use by qualified healthcare professionals only. These devices are to be used by physicians, nurses, respiratory therapists, and other trained medical practitioners to detect and study heart, lung, and other body sounds for physical assessment and diagnostic purposes. They are acoustic medical devices designed to transmit body sounds from a patient to the healthcare provider.

Our stethoscopes are intended to be used as part of a comprehensive physical examination in conjunction with other clinical assessment tools and the healthcare professional's training and expertise. These devices require proper medical training to interpret the sounds detected and should not be used for self-diagnosis by patients or untrained individuals.

Indications for Use

Apex Stethoscopes are indicated for:

  • Auscultation of heart, lung, and other body sounds
  • Blood pressure assessment when used with a sphygmomanometer
  • General physical assessment procedures requiring auscultation

Contraindications

There are no known contraindications for the use of Apex Stethoscopes when used as intended by qualified healthcare professionals.

Apex Stethoscopes are non-electronic acoustic devices and do not contain electrical components. They are not intended for use in conjunction with electronic patient monitoring systems or environments requiring MRI-safe labeling.

Warnings and Precautions

  • Apex Stethoscopes are not intended for use in diagnosing specific conditions without clinical correlation and professional medical judgment.
  • The devices should be properly cleaned and disinfected between patient uses to prevent cross-contamination.
  • Users should follow proper auscultation techniques as per their professional training.
  • These devices should not be exposed to extreme temperatures, as this may affect acoustic performance.
  • Patients with sensitive skin may experience discomfort from contact with stethoscope materials.
  • Do not store the device in a vehicle, near heat sources, or in environments subject to high humidity, which may affect tubing integrity and acoustic performance.

Product Materials and Safety

Apex Stethoscopes are manufactured using:

  • Stainless steel for chestpieces
  • PVC tubing materials
  • Components selected for appropriate medical device use

The responsibility for material compliance and biocompatibility requirements rests with the manufacturer, who is obligated to meet all applicable FDA standards for Class I medical devices.

Cleaning and Maintenance

To maintain proper function and extend the life of your Apex Stethoscope, we recommend:

  • Regular cleaning with 70% isopropyl alcohol or mild soap and water
  • Avoiding immersion in liquids
  • Periodic inspection of all components for wear or damage
  • Replacement of worn ear tips to maintain acoustic seal
  • Storage away from extreme temperatures and direct sunlight

Detailed cleaning instructions are provided in the product documentation included with each stethoscope.

Adverse Event Reporting

If you experience any adverse event or product problem with an Apex stethoscope, please report it to:

  1. Apex Bioacoustics Inc at help@apexbioacoustics.com
  2. The FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch or by calling 1-800-FDA-1088

Professional Use

Apex Stethoscopes are medical devices intended for professional use only. We encourage only trained healthcare professionals to use our stethoscopes. While the product is available to the general public, auscultation requires medical knowledge and clinical context for safe and accurate use.

Healthcare students should use these devices only as part of their supervised clinical training programs, following the guidance of their instructors and clinical preceptors. If you are a student or non-professional, we recommend using the stethoscope only under qualified supervision.

Contact Information

For questions related to our medical devices or regulatory compliance:

Email: help@apexbioacoustics.com

Phone: (916) 750-7466

Mail: Apex Bioacoustics Inc, 1420 E. Roseville Parkway, Suite 140 #514, Roseville, CA 95661

This Medical Device Statement was last updated on April 10, 2025, and will be reviewed annually or when significant changes are made to our products or applicable regulations.