Cranial Motion Measurement Device

POP · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1630

Classification

FDA Product Code: POP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1630
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 0

Source

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