510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013094Substantially Equivalent

Orthosonix Energex

Orthosonix, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013094 is the FDA 510(k) clearance record for ORTHOSONIX ENERGEX, a class II device, cleared for Orthosonix, Inc. on under FDA product code NHH (Device, Discharge, Electrostatic (For Pain Relief)). FDA's definition for product code NHH reads: "An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain". FDA records list one 510(k) clearance for Orthosonix, Inc. As of , FDA records show no recalls naming K013094.

Clearance record

Decision date
Received
(88 days to decision)
Product code
NHH Device, Discharge, Electrostatic (For Pain Relief)
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Orthosonix, Inc. 615 7th St. NE, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code NHH

Trailing 12 months

FDA records hold no clearances under product code NHH in the trailing twelve months.

FDA records show no clearances under product code NHH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260