Natures Pillows, Inc. and Top Dog Direct, LLC

Warning LetterOpen

William McAlister Official Correspondent Natures Pillows, Inc. and Top Dog Direct, LLC 402 Middletown Blvd, Suite 216 Langhorne , PA 19047 United States (b)(6)@topdogdirect.comIssued Aug 7, 2024Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateAug 7, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Natures Pillows, Inc. and Top Dog Direct, LLC
Location: William McAlister Official Correspondent Natures Pillows, Inc. and Top Dog Direct, LLC 402 Middletown Blvd, Suite 216 Langhorne , PA 19047 United States (b)(6)@topdogdirect.com
FEI Number: N/A
Country: United States
Issue Date: August 07, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Natures Pillows, Inc. and Top Dog Direct, LLC were cited for illegally marketing the Clean Zone CPAP Sanitizer, a medical device intended to disinfect CPAP therapy equipment, without required FDA premarket approval or an approved Investigational Device Exemption (IDE). The company violated the Federal Food, Drug, and Cosmetic Act by failing to obtain either a Premarket Approval (PMA) application or submit a premarket notification (510(k)) before distributing the device in interstate commerce. The device was found to be both adulterated and misbranded under FDA regulations due to the absence of these required regulatory submissions.

Natures Pillows, Inc. and Top Dog Direct, LLC FDA Warning Letter, August 7, 2024