510(k) K013094
K013094 is an FDA 510(k) premarket notification submitted by Orthosonix, Inc. for the device "ORTHOSONIX ENERGEX". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code NHH (Device, Discharge, Electrostatic (For Pain Relief)), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2001
- Date Received
- September 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Discharge, Electrostatic (For Pain Relief)
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- NE
- Submission Type
An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain