FDA device listing

NerveSpa Dual,NerveSpa Pro,Ultima OTC

FDA device listing 1647637601 · PAIN MANAGEMENT TECHNOLOGIES

Key facts

Proprietary names NerveSpa Dual,NerveSpa Pro,Ultima OTC
Owner/operator PAIN MANAGEMENT TECHNOLOGIES
Owner/operator number 9002150
Premarket submissions K140168
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 PAIN MANAGEMENT TECHNOLOGIES
Establishment registrations 1528161
FEI numbers 1000122747
Establishment operations Complaint File Establishment
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

Browse all FDA device listings