DeviceClearance

Product code NHH— Physical Medicine

ENERGEX

Classification name
Device, Discharge, Electrostatic (For Pain Relief)
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Total cleared
2
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code NHH under 21 CFR 890.5500, via openFDA

Market context for product code NHH

FDA has cleared 2 devices under product code NHH between 2001 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHH

Recent clearances under product code NHH

Data sourced from openFDA. This site is unofficial and independent of the FDA.