FDA device listing

Solax Powered Wheelchair, Model: S7101, S7103

FDA device listing 1468097833 · Guangdong Prestige Technology Co., Ltd.

Key facts

Proprietary names Solax Powered Wheelchair, Model: S7101, S7103
Owner/operator Guangdong Prestige Technology Co., Ltd.
Owner/operator number 10043023
Premarket submissions K182400
Product codes ITI
Device names ITI - Wheelchair, Powered
Device class Class II
Classification regulations (21 CFR) 890.3860
Review panels Physical Medicine
Registered establishments Guangdong Prestige Technology Co., Ltd.
Establishment registrations 3008841035
FEI numbers 3008841035
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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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