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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: LED PDT Device (Model:PDT21 PDT22 PDT23 PDT24 PDT25); Red Light Therapy Blanket (Model:BL-H1,BL-H2,BL-H3,BL-H4,BL-H5); Red Light Therapy Cap (Model:HT-H11,HT-H12,HT-H13,HT-H14,HT-H15); Red Light Therapy Pad (Model:PAD26,PAD27,PAD28,PAD29,PAD30); Red Light Therapy Panel(Model:PL-P30,PL-P60,PL-P90,PL-P150,PL-P200,PL-H06,PL-H07,PL-H08,PL-H09,PL-H10
Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
Product Code: ILY
Device Class: 2
Regulation Number: 890.5500
Medical Specialty: Physical Medicine
Registered Establishment Name: QINJI ELECTRONIC TECHNOLOGY (SUZHOU) CO., LTD.
Registered Establishment Number: 3044921223
Owner/Operator: Qinji Electronic Technology (Suzhou) Co., Ltd.
Owner/Operator Number: 10095443
Establishment Operations: Manufacturer
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