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FDA 510(k)

FastFit EMS System

K-Number: K192161 · 2020-01-22

ApplicantFast Fit, LLC
Decision Date2020-01-22
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FastFit EMS System is a medical device manufactured by Fast Fit, LLC. It received FDA 510(k) clearance on 2020-01-22 under approval number K192161. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FastFit EMS System?

FastFit EMS System is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by Fast Fit, LLC. The 510(k) number is K192161.

When was FastFit EMS System approved by the FDA?

FastFit EMS System received FDA 510(k) clearance on 2020-01-22, under approval number K192161.

What company makes FastFit EMS System?

FastFit EMS System is manufactured by Fast Fit, LLC.

What is the FDA product code for FastFit EMS System?

The FDA product code for FastFit EMS System is NGX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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