Goniometer With Electrodes

NKI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.1500

Classification

FDA Product Code: NKI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.1500
Review panel: NE
Medical specialty: Orthopedic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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