Atlas FDA

NHH

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Device, Discharge, Electrostatic (For Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5500
Medical specialty
Physical Medicine
Flags
Third-party review eligible
FDA 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
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RecordFirmDate
ENERGEX (K042686)Energex Systems, Inc.2005-06-16
ORTHOSONIX ENERGEX (K013094)Orthosonix, Inc.2001-12-14

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