FDA device listing

ABDUCTION PILLOW CONTOURED,Maternity Belt

FDA device listing 1840340271 · Breg Inc

Key facts

Proprietary names ABDUCTION PILLOW CONTOURED,Maternity Belt
Owner/operator Breg Inc
Owner/operator number 10041297
Product codes FSD
Device names FSD - Binder, Abdominal
Device class Class I
Classification regulations (21 CFR) 880.5160
Review panels General Hospital
Registered establishments BREG, INC., BREG, INC.,, BREG MEXICO, S. DE R.L. DE C.V. (4)
Establishment registrations 2028253, 3010694026, 3027500264
FEI numbers 1000125378, 3010694026, 3027500264
Establishment operations 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

Browse all FDA device listings