FDA device listing

Abdominal massage device,Electric Massage,Electric Neck Beauty Instrument,Eye massage device,Eyes Beauty Instrument,FACE…

FDA device listing 1181798811 · Brain Health Spectrum (Chengdu) Artificial Intelligence Tech

Key facts

Proprietary names Abdominal massage device,Electric Massage,Electric Neck Beauty Instrument,Eye massage device,Eyes Beauty Instrument,FACE & BODYSCULPTING MASSAGER,Foot massage device,Hand massage device,Head massage device,Headrest massage device,Hip massage device,Hot&cold Beauty Instrument,Knee massager,Leg massage device,Massage beauty device,Massage bed,Massage chair,Massage Facial Beauty Instrument,Massage…
Owner/operator Brain Health Spectrum (Chengdu) Artificial Intelligence Tech
Owner/operator number 10095091
Product codes ISA
Device names ISA - Massager, Therapeutic, Electric
Device class Class I
Classification regulations (21 CFR) 890.5660
Review panels Physical Medicine
Registered establishments BRAIN HEALTH SPECTRUM (CHENGDU) ARTIFICIAL INTELLIGENCE TECHNOLOGY CO., LTD.
Establishment registrations 3043709874
FEI numbers 3043709874
Establishment operations Foreign Exporter, Manufacturer, 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

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