FDA device listing

ReGenElite Wearable Magnetotherapy Model 40140

FDA device listing 1761792562 · Pulsar Scientific, LLC

Key facts

Proprietary names ReGenElite Wearable Magnetotherapy Model 40140
Owner/operator Pulsar Scientific, LLC
Owner/operator number 10081867
Product codes ISA
Device names ISA - Massager, Therapeutic, Electric
Device class Class I
Classification regulations (21 CFR) 890.5660
Review panels Physical Medicine
Registered establishments PULSAR SCIENTIFIC, LLC
Establishment registrations 3010256111
FEI numbers 3010256111
Establishment operations 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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