Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


In Brief: Stimulator consumer alert

This article was originally published in The Gray Sheet

Executive Summary

Stimulator consumer alert: Electrical "stimulator" device has not been approved by the agency and its manufacturers have not "complied with any FDA regulations" governing medical devices, FDA says in an Aug. 28 consumer alert. The device, which FDA says is an electric gas barbecue grill igniter outfitted with finger grips and an accessory called the Xtender, are promoted for relieving headaches, back pain, arthritis, stress, menstrual cramps, earaches, nosebleeds, flu and other ailments. FDA obtained a preliminary injunction against Universal Management Services and Natural Choice, both of Akron, Ohio, seeking to stop advertising, sale and distribution of the products in January. According to FDA staffers, the agency is investigating whether Universal Management is taking orders or selling the product in violation of the injunction, which was originally filed in December 1995 ("The Gray Sheet" Feb. 12, 1996, I&W-13). Of the six firms FDA identifies as having received warning letters in the past three years about marketing of the device (Natural Innovations, Canton, Ohio; Gandee Chiropractic Life Center, Akron, Ohio; Self-Care, Emeryville, Calif.; Magna Plus, Twinsburg, Ohio; Bright Marketing, Burlington, Iowa; and Crystaldyne, Scottsdale, Ariz.), two may have ties to Universal Management, the agency says. FDA believes two of the six firms have stopped selling the device...

You may also be interested in...

Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases

Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.

venBio Raises $394m To Fund Biopharmas Through Human Proof-Of-Concept

Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.

FDA Wants To Put Hep C Tests On 510(k) Pathway

The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts