FDA device listing
Easy@Home Electronic Pain Relief Stimulator Replacement Pads (ETP019),Easy@Home Electronic Pulse Stimulator…
FDA device listing 1179425696 · EASY HEALTHCARE CORPORATION
Key facts
| Proprietary names | Easy@Home Electronic Pain Relief Stimulator Replacement Pads (ETP019),Easy@Home Electronic Pulse Stimulator (EHE015BLE),Easy@Home Foot Massage Mat (EFM-05R),Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads (ETP015) |
|---|---|
| Owner/operator | EASY HEALTHCARE CORPORATION |
| Owner/operator number | 10052041 |
| Premarket submissions | K162517 |
| Product codes | IRT, NGX, NUH, NYN |
| Device names | IRT - Pad, Heating, Powered, NGX - Stimulator, Muscle, Powered, For Muscle Conditioning, NUH - Stimulator, Nerve, Transcutaneous, Over-The-Counter, NYN - Stimulator, Electrical, Transcutaneous, For Arthritis |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5890, 890.5740, 890.5850 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | EASY HEALTHCARE CORPORATION |
| Establishment registrations | 3012725363 |
| FEI numbers | 3012725363 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database