FDA device listing

NEOPULSE

FDA device listing 2066121613 · Neotech Products LLC

Key facts

Proprietary names NEOPULSE
Owner/operator Neotech Products LLC
Owner/operator number 2025917
Product codes FQM
Device names FQM - Bandage, Elastic
Device class Class I
Classification regulations (21 CFR) 880.5075
Review panels General Hospital
Registered establishments NEOTECH PRODUCTS, LLC
Establishment registrations 2025917
FEI numbers 2025917
Establishment operations Manufacturer, Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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