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REMSleep Holdings Inc. Receives 510(K) Clearance on Product
REMSleep Holdings Inc. Receives 510(K) Clearance on Product.
About this update from Remsleep Holdings, Inc.
[{"type":"text","content":"\n CLEARWATER, Fla., July 09, 2024 (GLOBE NEWSWIRE) -- REMSleep Holdings, Inc. (OTCQB: RMSL) announces the company has been awarded 510(K) Clearance for the new Deltawave CPAP Pillows Interface mask. The company would like to share the following correspondence with its shareholders: Re: K233415Trade/Device Name: DELTAWAVE Nasal Pillows SystemRegulation Number: 21 CFR 868.5905Regulation Name: Noncontinuous Ventilator (IPPB)Regulatory Class: Class IIProduct Code: BZDDated: October 4, 2023Received: October 10, 2023 Dear Judy Strzepek: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidanc...