Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Class II · Cleared Jan 28, 2026
| K-number | K251622 |
| Device name | Hand Massager (SM004D) |
| Applicant | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. |
| Product code | IRP |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.5650 |
The Hand Massager (SM004D) is a powered inflatable tube massager intended for temporary relief of minor muscle aches and pains in the hand and wrist, and to temporarily increase local circulation in generally healthy adults. It is particularly suitable for relaxing hand muscles after repetitive activities. The device is charged via USB cable with a 5V power adapter and features user-adjustable treatment cycles of 10, 15, or 20 minutes.
The proposed device operates at 5W/DC 5V with a rechargeable battery, compared to the predicate's 12VDC power supply. Maximum single-use treatment is 20 minutes versus the predicate's 179 minutes. The device is lighter (0.97 kg) with a smaller garment sleeve (29 cm) than the predicate (1.81-2.18 kg, 61-84 cm). It uses rayon fabric instead of polyurethane laminate. The proposed device offers intensity levels (L1-L6) and a massage sequence mode (P mode) versus the predicate's two sequential inflation patterns (Mode A and B). Both maintain the same operational pressure range (0-26.6 kPa) and sequential pneumatic compression principle.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general safety and essential performance), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC TR 60601-4-2:2016 (electromagnetic immunity), IEC 60601-1-11:2015 (home healthcare environment requirements), ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (skin irritation).
The proposed device is substantially equivalent to the predicate (Rapid Reboot) because both are Class II powered inflatable tube massagers with the same indications for use, same product code (IRP), and same regulatory classification (21 CFR 890.5650). All design differences—including reduced treatment duration, lighter weight, different materials, and alternative user interface—represent design optimizations without introducing new risks. Both devices comply with identical safety standards (IEC 60601-1) and maintain the same fundamental sequential pneumatic compression principle with comparable operational pressure ranges.
View the full FDA submission: accessdata.fda.gov