Decision Date2026-01-28
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Hand Massager (SM004D) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251622. 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 Hand Massager (SM004D)?
Hand Massager (SM004D) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. The 510(k) number is K251622.
When did Hand Massager (SM004D) receive FDA 510(k) clearance?
Hand Massager (SM004D) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251622.
Who is the listed applicant for Hand Massager (SM004D)?
The FDA 510(k) record lists Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hand Massager (SM004D)?
The FDA product code for Hand Massager (SM004D) is IRP.
Related Devices (Code: 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.