NHH — Device, Discharge, Electrostatic (For Pain Relief) Class II

FDA Device Classification

FDA product code NHH covers "Device, Discharge, Electrostatic (For Pain Relief)", a Class II medical device regulated under 21 CFR 890.5500. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NHH
Device Class
Class II
Regulation Number
890.5500
Submission Type
Review Panel
NE
Medical Specialty
Physical Medicine
Implant
No

Definition

An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042686energex systemsENERGEXJune 16, 2005
K013094orthosonixORTHOSONIX ENERGEXDecember 14, 2001