Cleared Traditional

Hand Massager (SM004D)

K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Physical Medicine

Jan 2026

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K251622 is an FDA 510(k) clearance for the Hand Massager (SM004D), a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 28, 2026, 245 days after receiving the submission on May 28, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K251622 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2025
Decision Date	January 28, 2026
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF