# K251622: Hand Massager (SM004D)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
- Decided: Jan 28, 2026 after 245 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K850316 (1985). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203552: Rapid Reboot, Rapid Reboot Recovery Products, LLC (2020) Summary page 5.

## Indications for use
The Hand Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.

Source page: https://510kreport.com/device/K251622
Methodology: https://510kreport.com/methodology