Decision Date2024-11-14
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Xrecovery (XR-001) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xinrun Electric Appliances Co, Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K242940. 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 Xrecovery (XR-001)?
Xrecovery (XR-001) is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Shenzhen Xinrun Electric Appliances Co, Ltd.. The 510(k) number is K242940.
When did Xrecovery (XR-001) receive FDA 510(k) clearance?
Xrecovery (XR-001) received FDA 510(k) clearance on 2024-11-14, under 510(k) number K242940.
Who is the listed applicant for Xrecovery (XR-001)?
The FDA 510(k) record lists Shenzhen Xinrun Electric Appliances Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xrecovery (XR-001)?
The FDA product code for Xrecovery (XR-001) is IRP.
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Official Source
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