FDA device listing

Dr Scholls 2 in 1 Bunion and Toe Corrector,Plantar Fasciitis Arch Support Sleeve

FDA device listing 1355797360 · SCHOLL'S WELLNESS COMPANY

Key facts

Proprietary names Dr Scholls 2 in 1 Bunion and Toe Corrector,Plantar Fasciitis Arch Support Sleeve
Owner/operator SCHOLL'S WELLNESS COMPANY
Owner/operator number 10061238
Product codes IQI
Device names IQI - Orthosis, Limb Brace
Device class Class I
Classification regulations (21 CFR) 890.3475
Review panels Physical Medicine
Registered establishments SCHOLL'S WELLNESS COMPANY
Establishment registrations 3015961134
FEI numbers 3015961134
Establishment operations Complaint File Establishment, 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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