WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K251622

510(k) cleared

Hand Massager (SM004D)

Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 28, 2026 · K251622

FDA cleared the Hand Massager (SM004D) from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. on Jan 28, 2026 under K251622, a traditional 510(k). The device falls under product code IRP, Massager, Powered Inflatable Tube, regulated at 21 CFR 890.5650 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on May 28, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251622?

K251622 is the FDA 510(k) for Hand Massager (SM004D), submitted by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. FDA's decision date was Jan 28, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Hand Massager (SM004D)?

Ningbo Zhenhai Yihao Electronic Technology Co., Ltd., based in Ningbo, is the applicant of record for K251622.

How long did the K251622 review take?

FDA received the submission on May 28, 2025 and issued its decision on Jan 28, 2026, 245 days later.

← All decisions in January 2026