Is this your brand? Sign in to claim ownership.
Sign in to claim this brandZHANGZHOU EASEPAL INNOVATION CO., LTD.
US
Last updated May 23, 2026
What ZHANGZHOU EASEPAL INNOVATION CO., LTD. makes
Zhangzhou Easepal Innovation Co., Ltd. manufactures hand-held electric massagers and pneumatic massage devices designed for personal use, including models under the Homedics brand.
These devices are regulated under FDA classifications, including Class I and Class II, with some entries listed via the 510(k) pathway and the FDA’s Unique Device Identifier (UDI) system.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Zhangzhou Easepal Innovation Co., Ltd. primarily manufacture?
Zhangzhou Easepal Innovation Co., Ltd. specializes in hand-held electric massagers and pneumatic massage devices. These products are designed for personal use, often marketed under the Homedics brand. The focus is on devices intended to provide muscle relaxation and relief through mechanical stimulation.
Where is Zhangzhou Easepal Innovation Co., Ltd. based, and how does that affect its regulatory standing?
The company is based in the US, which means its devices fall under the jurisdiction of the FDA. Since the US is the manufacturer’s market, regulatory submissions—such as 510(k) clearances or UDI listings—are required to demonstrate compliance with FDA requirements for Class I and Class II devices.
Which regulatory registries or databases list devices manufactured by Zhangzhou Easepal Innovation Co., Ltd.?
Devices from Zhangzhou Easepal Innovation Co., Ltd. appear in the FDA’s 510(k) registry for premarket submissions and the FDA’s Unique Device Identifier (UDI) system. These registries track device classifications (Class I or Class II) and ensure traceability for compliance and post-market surveillance.
How are devices from Zhangzhou Easepal Innovation Co., Ltd. classified under FDA regulations?
The company’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. Classification determines the regulatory pathway and submission requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 546535934
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Homedics | NMS-240HJA-2 | FDA UDI | Class I | Active |
| Homedics | FMS-370HJA-2 | FDA UDI | Class I | Active |
| Homedics | NMSQ-216HJA-2 | FDA UDI | Class I | Active |
| Homedics | NMS-377HJ-TN | FDA UDI | Class I | Active |
| Homedics | NMS-390HJ-2 | FDA UDI | Class I | Active |
| Homedics | FMS-370HJ | FDA UDI | Class I | Active |
| Homedics | NMS-685HJ | FDA UDI | Class I | Active |
| Homedics | NMSQ-217HJ-TN | FDA UDI | Class I | Active |
| Homedics | NMS-240HJB-2 | FDA UDI | Class I | Active |
| Homedics | NMS-390HJ | FDA UDI | Class I | Active |
| Homedics | SR-10J | FDA UDI | Class I | Active |
| Homedics | NMS-390HJ-WMT | FDA UDI | Class I | Active |
| Homedics | NMS-240HJA | FDA UDI | Class I | Active |
| Homedics | SPE-110H-2 | FDA UDI | Class I | Active |
| medisana | EP-1129 | FDA UDI | Class II | Active |
| Homedics | SP-250HJ | FDA UDI | Class I | Active |
| Homedics | B-NMS-229J | FDA UDI | Class I | Active |
| Homedics | FMS-370HJ | FDA UDI | Class I | Active |
| medisana | EP-1129 | FDA UDI | Class II | Active |
| Homedics | HHP-735HJ | FDA UDI | Class I | Active |
| Homedics | SPE-CP110HJ | FDA UDI | Class I | Active |
| Homedics | SPE-110HA-2 | FDA UDI | Class I | Active |
| Homedics | NMSQ-216HJAGY-2 | FDA UDI | Class I | Active |
| Homedics | NMSQ-216HJ-GY-2 | FDA UDI | Class I | Active |
| Homedics | HHP-810HJ | FDA UDI | Class I | Active |
| Leg and Foot Air Wave Pressure Therapy Device | K223464 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Zhangzhou Easepal Innovation Co., Ltd Zhangzhou Fujian · CN FEI 3017103444