HD 8Ch Wrist Array
K-Number: K252587 · 2026-04-14
ApplicantShenzhen RF Tech Co., Ltd.
Decision Date2026-04-14
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HD 8Ch Wrist Array is a medical device manufactured by Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-14 under approval number K252587. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HD 8Ch Wrist Array?
HD 8Ch Wrist Array is a medical device that received FDA 510(k) clearance on 2026-04-14. It is manufactured by Shenzhen RF Tech Co., Ltd.. The 510(k) number is K252587.
When was HD 8Ch Wrist Array approved by the FDA?
HD 8Ch Wrist Array received FDA 510(k) clearance on 2026-04-14, under approval number K252587.
What company makes HD 8Ch Wrist Array?
HD 8Ch Wrist Array is manufactured by Shenzhen RF Tech Co., Ltd..
What is the FDA product code for HD 8Ch Wrist Array?
The FDA product code for HD 8Ch Wrist Array is MOS.
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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.