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FDA 510(k)

Hand Massager (SM004D)

K-Number: K251622 · 2026-01-28

ApplicantNingbo Zhenhai Yihao Electronic Technology Co., Ltd.
Decision Date2026-01-28
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hand Massager (SM004D) is a medical device manufactured by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under approval 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. It is manufactured by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. The 510(k) number is K251622.

When was Hand Massager (SM004D) approved by the FDA?

Hand Massager (SM004D) received FDA 510(k) clearance on 2026-01-28, under approval number K251622.

What company makes Hand Massager (SM004D)?

Hand Massager (SM004D) is manufactured by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd..

What is the FDA product code for Hand Massager (SM004D)?

The FDA product code for Hand Massager (SM004D) 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.

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