FDA device listing

Kit, First Aid, Talking

FDA device listing 1998000264 · Shenzhen WAP-health Technology Co., Ltd.

Key facts

Owner/operator Shenzhen WAP-health Technology Co., Ltd.
Owner/operator number 10060544
Product codes OVR
Device names OVR - Kit, First Aid, Talking
Device class Class I
Classification regulations (21 CFR) 878.4014
Review panels General & Plastic Surgery
Registered establishments SHENZHEN WAP-HEALTH TECHNOLOGY CO., LTD.
Establishment registrations 3011647251
FEI numbers 3011647251
Establishment operations Repackager/Relabeler
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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