Regulation

FDA-cleared EMS suits: which brands have a 510(k), and what it means

Almost every EMS brand says “FDA cleared”. We looked each one up in the FDA database. Here are the numbers, and the brands where we found none.

By the bestEMSsuits.com editorial teamUpdated September 2026Affiliated with Visionbody

A folded EMS suit next to a technical document and a magnifying glass on a white desk
Illustration. The image does not show a specific product.

Cleared is not approved

Whole-body EMS systems are Class II medical devices under regulation 21 CFR 890.5850. A manufacturer files a 510(k) showing that its device is substantially equivalent to one already on the market, and the FDA clears it. That is not an approval, and no EMS suit is “FDA approved”. The FDA also states that no EMS device has been cleared for weight loss, girth reduction or “rock hard” abs.[1]

A clearance still matters. The manufacturer has submitted electrical safety testing, and the 510(k) summary publishes the device’s real parameters. It also states whether the device is for over-the-counter or prescription use.

What we found in the FDA database

Brand510(k) numberDecisionStatus
Visionbody and Visionbody ProK222386Feb 2023Verified, summary lists prescription use
KatalystK190966Feb 2020Verified, over the counter
PEPPERK233770Jan 2025Verified
miha bodytecK182519, K201975, K2214982019–2022Verified, prescription use
XBodyK190038, K221200, K2429262019–2025Verified, trained operator
E-FitK133225, K2021482014, 2021Verified
TitanBodyNone publishedClaimed, no record found under the brand name
SQAINone publishedClaimed, no record found under the brand name
OHM FitnessNone publishedNo FDA statement found

Checked on 20 September 2026 in the FDA 510(k) database.[2] A device can be cleared under its manufacturer’s name, so “no record found” does not prove a claim is false. It means you cannot check it.

What to ask a brand

  • What is your 510(k) number?
  • Is the clearance for over-the-counter or prescription use?
  • Does it cover the exact model you are selling me?

A brand with a genuine clearance can answer in one line. You can check the number yourself in the FDA database in under a minute.

And outside the US?

In the EU, a device sold with medical claims needs CE marking under the Medical Device Regulation. Most EMS suit brands publish little about their CE status, and we award no points for certifications we cannot see.

Frequently asked questions

Which EMS suits are FDA cleared?

We verified 510(k) clearances in the FDA database for Visionbody (K222386), Katalyst (K190966), PEPPER (K233770), miha bodytec, XBody and E-Fit. TitanBody and SQAI claim clearance but publish no number.

Is FDA cleared the same as FDA approved?

No. A 510(k) clearance means the device is substantially equivalent to a legally marketed device. Approval is a different, stricter process that EMS suits do not go through.

Sources

  1. U.S. Food and Drug Administration. Electronic Muscle Stimulators (consumer information) – www.fda.gov/medical-devices/consumer-products/electronic-muscle-stimul
  2. U.S. Food and Drug Administration. 510(k) Premarket Notification database – www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm