Powered muscle stimulators

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

Albert P. Manudhane, Sophie Wang, Harib H. Ezaldein, Jeffrey Scott

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalJournal of Dermatological Treatment
DOIs
StateAccepted/In press - Jan 1 2019
Externally publishedYes

Fingerprint

Esthetics
Equipment and Supplies
Muscles
Databases
Blood Circulation
Myalgia
Muscle Strength
Marketing
Venous Thrombosis
Health Personnel
Cross-Sectional Studies
Pain
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Dermatology

Cite this

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.

In: Journal of Dermatological Treatment, 01.01.2019.

Research output: Contribution to journalArticle

@article{780e24fa04d64680bf9aa398dbffc7dd,
title = "Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit",
abstract = "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.",
keywords = "510(k), abdominal muscles, MAUDE, muscle blood flow, Muscle conditioning, muscle toning, pain relief, premarket approval, slendertone, transcutaneous electrical muscle stimulation",
author = "Manudhane, {Albert P.} and Sophie Wang and Ezaldein, {Harib H.} and Jeffrey Scott",
year = "2019",
month = "1",
day = "1",
doi = "10.1080/09546634.2019.1587148",
language = "English (US)",
journal = "Journal of Dermatological Treatment",
issn = "0954-6634",
publisher = "Informa Healthcare",

}

TY - JOUR

T1 - Powered muscle stimulators

T2 - an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit

AU - Manudhane, Albert P.

AU - Wang, Sophie

AU - Ezaldein, Harib H.

AU - Scott, Jeffrey

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - 510(k)

KW - abdominal muscles

KW - MAUDE

KW - muscle blood flow

KW - Muscle conditioning

KW - muscle toning

KW - pain relief

KW - premarket approval

KW - slendertone

KW - transcutaneous electrical muscle stimulation

UR - http://www.scopus.com/inward/record.url?scp=85063231965&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063231965&partnerID=8YFLogxK

U2 - 10.1080/09546634.2019.1587148

DO - 10.1080/09546634.2019.1587148

M3 - Article

JO - Journal of Dermatological Treatment

JF - Journal of Dermatological Treatment

SN - 0954-6634

ER -