Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.

Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.

Manudhane Albert P; Wang Sophie; Ezaldein Harib H; Scott Jeffrey F

The Journal of dermatological treatment

2019

2019-02

INTRODUCTION: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators. METHODS: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage. RESULTS: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers. DISCUSSION: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.

premarket approval; 510(k); abdominal muscles; MAUDE; muscle blood flow; Muscle conditioning; muscle toning; pain relief; slendertone; transcutaneous electrical muscle stimulation

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