Soulaire Corporation

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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).

Passage 2

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).

Passage 3

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.