EMPOWR Knee
K-Number: K252974 · 2025-12-19
ApplicantEncore Medical L.P.
Decision Date2025-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPOWR Knee is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2025-12-19 under approval number K252974. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EMPOWR Knee?
EMPOWR Knee is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Encore Medical L.P.. The 510(k) number is K252974.
When was EMPOWR Knee approved by the FDA?
EMPOWR Knee received FDA 510(k) clearance on 2025-12-19, under approval number K252974.
What company makes EMPOWR Knee?
EMPOWR Knee is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR Knee?
The FDA product code for EMPOWR Knee is JWH.
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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.