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510(k) Data Aggregation
K Number
K233667Device Name
Facial Toning device (UIC-189); Facial Toning device (UIC-589)
Manufacturer
Body Trim Industrial Co., Ltd
Date Cleared
2024-02-12
(89 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Body Trim Industrial Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.
Device Description
The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.
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