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FDA 510(k)

Compex Sport Elite 3.0

K-Number: K201653 · 2020-11-27

ApplicantDjo, LLC
Decision Date2020-11-27
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Compex Sport Elite 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Djo, LLC. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201653. 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 Compex Sport Elite 3.0?

Compex Sport Elite 3.0 is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Djo, LLC. The 510(k) number is K201653.

When did Compex Sport Elite 3.0 receive FDA 510(k) clearance?

Compex Sport Elite 3.0 received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201653.

Who is the listed applicant for Compex Sport Elite 3.0?

The FDA 510(k) record lists Djo, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compex Sport Elite 3.0?

The FDA product code for Compex Sport Elite 3.0 is NGX.

Other records listing Djo, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.