FDA device listing

GLOBALCARE MICRO 11 AND MICROCARE(TENS)

FDA device listing 1222894286 · Dongguan Bohuikang Technology Co.,Ltd

Key facts

Proprietary names GLOBALCARE MICRO 11 AND MICROCARE(TENS)
Owner/operator Dongguan Bohuikang Technology Co.,Ltd
Owner/operator number 10085234
Premarket submissions K903394
Product codes GZJ
Device names GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class Class II
Classification regulations (21 CFR) 882.5890
Review panels Neurology
Registered establishments DONGGUAN BOHUIKANG TECHNOLOGY CO.,LTD
Establishment registrations 3023330992
FEI numbers 3023330992
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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