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U.S. Department of Health and Human Services

Product Classification
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Device oral removable retainer for weight management
Regulation Description Oral removable palatal space occupying device for weight management and/or weight loss.
Definition A removable oral device used during meals to limit food intake.
Physical State Stainless steel wire, electrical sensor and palatal mold (polymer)
Technical Method Intraorally limits bite size
Target Area Mouth
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeONY
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5981
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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