FDA device listing

Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

FDA device listing 1638326690 · Zhejiang Youha Medical Technology Co., Ltd

Key facts

Proprietary names Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)
Owner/operator Zhejiang Youha Medical Technology Co., Ltd
Owner/operator number 10090632
Premarket submissions K240329
Product codes ITI
Device names ITI - Wheelchair, Powered
Device class Class II
Classification regulations (21 CFR) 890.3860
Review panels Physical Medicine
Registered establishments Zhejiang Youha Medical Technology Co., Ltd
Establishment registrations 3017278503
FEI numbers 3017278503
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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