FDA device listing

Easy@Home Electronic TENS Pulse Massager (EHE010),Easy@Home Mini Electronic Pulse Stimulator (EHE029G),Easy@Home…

FDA device listing 1702588502 · EASY HEALTHCARE CORPORATION

Key facts

Proprietary names Easy@Home Electronic TENS Pulse Massager (EHE010),Easy@Home Mini Electronic Pulse Stimulator (EHE029G),Easy@Home Wireless TENS Pulse Massager (EHE016)
Owner/operator EASY HEALTHCARE CORPORATION
Owner/operator number 10052041
Premarket submissions K141260
Product codes NUH
Device names NUH - Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class Class II
Classification regulations (21 CFR) 882.5890
Review panels Neurology
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
  • 1–9 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

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