Dr. Joel Kaplan Inc.

Warning LetterOpen

Mr. Shumuel Itshaki Chief Executive Officer Dr. Joel Kaplan Inc. 3350 Market St. Ste B San Diego , CA 92102-3348 United StatesFEI 3001890611Issued Jan 8, 2024Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3001890611.

Violations13

Issue DateJan 8, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Dr. Joel Kaplan Inc.
Location: Mr. Shumuel Itshaki Chief Executive Officer Dr. Joel Kaplan Inc. 3350 Market St. Ste B San Diego , CA 92102-3348 United States
FEI Number: 3001890611
Country: United States
Issue Date: January 08, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Dr. Joel Kaplan Inc., a manufacturer and distributor of sexual health enhancement medical devices including the MegaVac Pump System and other products, violated FDA regulations by making unapproved and misbranded device claims. The company's product labeling and website made therapeutic claims such as stating the products would "increase in length and thickness," correct penile curvature, and expand blood vessels to improve erectile function—claims that classify these products as medical devices requiring FDA approval but which the company had not obtained. The FDA inspection conducted June 27-30, 2023, identified these violations, and despite the company's multiple responses between July and November 2023, the violations remained unresolved.

Dr. Joel Kaplan Inc. FDA Warning Letter, January 8, 2024