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510(k) Data Aggregation
K Number
K221189Device Name
OLIZ LTB-1000A
Manufacturer
LTBIO Co., Ltd.
Date Cleared
2022-08-29
(126 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LTBIO Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Device Description
The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.
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