Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

NHI · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5890

Classification

FDA Product Code: NHI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5890
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,

Market data

Cleared 510(k) submissions: 13
Registered establishments: 13

Source

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