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510(k) Data Aggregation
K Number
K242186Device Name
Neo Sculptor (OF-NEO001)
Manufacturer
Date Cleared
2024-09-17
(54 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
OFAN Intelligent Technology (Guangzhou) Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is indicated to be used for:
• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.
·Improvement of muscle tone and firmness, for strengthening muscles in arms.
Device Description
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