Air Compression Leg Massager (model: EMK-701)
K-Number: K222991 · 2023-03-15
Decision Date2023-03-15
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Air Compression Leg Massager (model: EMK-701) is a medical device manufactured by Xiamen Emoka Health Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-15 under approval number K222991. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Air Compression Leg Massager (model: EMK-701)?
Air Compression Leg Massager (model: EMK-701) is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Xiamen Emoka Health Science & Technology Co., Ltd.. The 510(k) number is K222991.
When was Air Compression Leg Massager (model: EMK-701) approved by the FDA?
Air Compression Leg Massager (model: EMK-701) received FDA 510(k) clearance on 2023-03-15, under approval number K222991.
What company makes Air Compression Leg Massager (model: EMK-701)?
Air Compression Leg Massager (model: EMK-701) is manufactured by Xiamen Emoka Health Science & Technology Co., Ltd..
What is the FDA product code for Air Compression Leg Massager (model: EMK-701)?
The FDA product code for Air Compression Leg Massager (model: EMK-701) is IRP.
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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.