DeviceClearance

Product code OBV— Neurology

MANDOMETER III

Classification name
Eating Disorder Conditioning Tool
Device class
Class 2
Regulation
21 CFR 882.5060
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.”

— U.S. Food and Drug Administration, device classification record for product code OBV under 21 CFR 882.5060, via openFDA

Market context for product code OBV

FDA has cleared 1 device under product code OBV, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OBV

Recent clearances under product code OBV

Data sourced from openFDA. This site is unofficial and independent of the FDA.