Eating Disorder Conditioning Tool

OBV · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5060

Classification

FDA Product Code: OBV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5060
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown