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WARNING LETTER
CMS # 675069

Re: External Counter Pulsation Device Model: Soulaire
Refer to CPT2301643

Dear Morad Soulati:

The United States Food and Drug Administration (FDA) has learned that your firm, Soulaire Corporation, is marketing the External Counterpulsation (ECP) System Model: Soulaire, an external counter-pulsating device under 21 CFR 870.5225, in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The ECP is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. However, as described below, your firm is marketing the product for multiple intended uses outside of its original clearance – examples include, but are not limited to: growth of new arteries, reduction or elimination of blood pressure medicine, helps reduce symptoms of COVID-19, excretes stem cells to repair organ dysfunction, regeneration of pancreatic tissue, and hair growth. Your firm has not provided any evidence to FDA to substantiate the safety or efficacy of these uses, and the Agency is currently unaware of any data or literature that supports these claims.

Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is 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, https://www.soulaire.com/, and determined that the ECP System Model: Soulaire 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), nor 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. The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o) because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The Soulaire device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).

Specifically, the External Counterpulsation System Model, Soulaire was cleared on August 28, 2020 under premarket notification K202108 for immediate use with the following indications:

“The External Counterpulsation System, Soulaire device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.”

However, your firm’s promotion of the Soulaire includes multiple statements regarding uses of the device which exceed the cleared indications for use statement (listed above), constitute major changes or modifications to the ECP’s intended use and for which your firm lacks clearance or approval. For example, a review of your firm’s website, https://www.soulaire.com/ ( accessed on December 7, 2023) revealed the following claims (please note this is not an all-inclusive list):

• “Soulaire… [g]rows new arteries (collaterals)”
• “…EECP circulates oxygenated blood through arteries and helps open new collaterals for blood to flow around blockages, like a natural bypass”
• “People who receive EECP report regulated blood pressure and reduction or elimination of blood pressure medication”
• “For patients with stroke, we have seen improvement in motor/neuro skills such as speaking and walking”
• “EECP pumps toxins for elimination by the kidneys helping the body detox/improve the immune system”
• “EECP therapy by Soulaire has shown significant potential in managing Long Term COVID symptoms, particularly those related to heart health”
• “EECP pumps oxygenated blood to the brain and grows new arteries (if there are blockages) and as a result memory and clarity improve.”
• “EECP grows new arteries and improves circulation to the legs.”
• “Experience a revolutionary approach to hair growth with the Soulaire EECP device.”
• “EECP therapy promotes the release of vascular endothelial growth factor, encouraging the development of new blood vessels, a process known as angiogenesis. This enhances the heart’s blood supply, reducing heart failure symptoms and improving overall cardiac function.”
• “Reverses effects of blood vessel aging by inhibiting arterial plaque accumulation and increasing nitric oxide production.”
• “Soulaire… [e]xcretes stem cells to repair organ dysfunction”
• “…patients with diabetes often see improved pancreatic function when EECP therapy regenerates pancreatic tissue to produce insulin and lower blood sugar levels.”
• “During EECP, arteries behind the eye receive increased oxygenated blood flow during EECP. People report that when they visit their optometrist he or she has lowered their prescription for eyeglasses.”

The above statements describe device intended uses for the External Counterpulsation System Model, Soulaire that differ significantly from those cleared in K202108 and constitute major changes or modifications to the device’s intended use for which your firm lacks clearance or approval (see 21 CFR 801.87(a)(3)(ii)). For example, the device claims to “improve[] pancreatic function” by “regenerating pancreatic tissue to produce insulin and lower blood sugar levels.” This and the other claims noted above from your website constitute device intended use claims under section 201(h) of the Act because they describe the product as being intended for use in the cure, mitigation, treatment, or prevention of disease (in this example, improving pancreatic function associated with diabetes), or to affect the structure or any function of the body (in this example, regenerating pancreatic tissue to produce insulin). Similarly, the Soulaire device claims to “reduce[] heart failure symptoms and improve[] overall cardiac function” (describing the product as being intended for use in the cure, mitigation, treatment, or prevention of disease), by promoting “the release of vascular endothelial growth factor, encouraging the development of new blood vessels” (affecting the structure or any function of the body).

Additionally, as described in the indications for use statement above, the External Counterpulsation System Model, Soulaire cleared in K202108 is “intended for use under the oversight of a healthcare professional”. Additionally, the cleared labeling for the Soulaire device includes the Rx Only Caution statement indicating that “Federal law restricts this device to sale by or on the order of a physician”. However, your website offers the Soulaire device for sale to “business, . . . home or sports team” which suggests the potential for sale and use of the Soulaire device without the order of a physician nor the oversight of a healthcare professional.

In addition, please note that, as described in Final Order 78 FR 79304 and 21 CFR 870.5225, external counter-pulsating (ECP) devices intended for certain uses—specifically, uses other than treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization—are classified as class III and thus require premarket approval. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.html.

Our office requests that Soulaire Corporation and all related/associated entities cease any activities that result in the misbranding or adulteration of the External Counterpulsation System Model: Soulaire, such as the commercial distribution of the device for the uses discussed above in addition to any other marketing claims/uses that have not received clearance or approval from the FDA.

Your firm should take prompt action to address any violations identified in this letter. Failure to address this matter promptly and adequately 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 business days from the date you receive this letter of the specific steps your firm has taken 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 (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. 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 any 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 by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the identification number CMS # 675069 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Catherine Wentz at Catherine.Wentz@fda.hhs.gov.

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

Sincerely yours,
/S/

Bram Zuckerman, MD
Director
OHT 2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health