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 a medical device manufactured by Djo, LLC. It received FDA 510(k) clearance on 2020-11-27 under approval 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. It is manufactured by Djo, LLC. The 510(k) number is K201653.
When was Compex Sport Elite 3.0 approved by the FDA?
Compex Sport Elite 3.0 received FDA 510(k) clearance on 2020-11-27, under approval number K201653.
What company makes Compex Sport Elite 3.0?
Compex Sport Elite 3.0 is manufactured by Djo, LLC.
What is the FDA product code for Compex Sport Elite 3.0?
The FDA product code for Compex Sport Elite 3.0 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.