September 18, 2025

WARNING LETTER
CMS # 713455

Dear Mr. Lih:

The United States Food and Drug Administration (FDA) is aware that your firm is marketing the LifeVac Rescue Suction Device in the United States without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The LifeVac Rescue Suction Device is an airway clearance device used for resuscitating a victim with an airway obstruction when current choking protocols have been followed without success. Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because, in relevant part, these are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has reviewed your firm’s website (www.lifevac.net) and marketing materials and determined that the LifeVac Rescue Suction Device is a Class III device under section 513(f)(1) of the Act, 21 U.S.C. § 360c(f)(1). This device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed.

In April and May of 2023, FDA notified your firm of the correct classification for your LifeVac Rescue Suction Device and discussed your firm submitting a premarket submission. On June 27, 2025, and June 30, 2025, FDA informed your firm that we expect you to cease marketing and distributing the LifeVac Rescue Suction Device until you have received authorization, and asked your firm to confirm that you agree to cease the marketing of your unauthorized device and provide us with a date by which you would do so. On August 4, 2025, FDA reiterated to your firm that the LifeVac Rescue Suction Device lacks marketing authorization and that continued marketing of the device is unauthorized. Your firm acknowledged receipt of these communications, but you continue to market and distribute the LifeVac Rescue Suction Device as of September 17, 2025.

FDA is concerned that your firm’s continued unauthorized marketing and distribution of the LifeVac Rescue Suction Device may put the public health and safety at risk. As FDA explained in an April 2024 Safety Communication, the safety and effectiveness of unauthorized antichoking devices being sold over the counter have not been established, and there are reports describing problems with the use of unauthorized anti-choking devices—including failure to resolve a choking incident due to lack of suction, bruising around the face, lips, and mouth, and scratches in the back of the throat. See FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication (April 22, 2024), available at https://www.fda.gov/medical-devices/safety-communications/fda-encourages-public-followestablished-choking-rescue-protocols-fda-safety-communication.

Your firm should take prompt action to address any violations identified in this letter, including immediately ceasing any activities that result in the adulteration of your products. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken or plans to take to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions that your firm has taken. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all of the violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Dr. Denise Hampton at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case [#713455]” when replying. If you have any questions about the contents of this letter, please contact: Dr. Denise Hampton at Denise.Hampton@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your firm. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.

Sincerely,
/S/

Kesia Alexander, PhD
Director (Acting)
OHT 1: Office of Ophthalmic, Anesthesia, Respiratory,
ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health