510(k) K013094
- Device
- ORTHOSONIX ENERGEX
- Applicant
- ORTHOSONIX, INC.
- 510(k) number
- K013094
- Product code
- NHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-14
- Date received
- 2001-09-17
- Regulation
- 890.5500
- Classification name
- Device, Discharge, Electrostatic (for Pain Relief)
- Medical specialty
- Physical Medicine
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL PAGANO
- Address
- 615 7th St. NE 1st Floor Washington DC US 20002 20002
Source Documents#
Other 510(k) Records For Product Code NHH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042686 | ENERGEX | Energex Systems, Inc. | 2005-06-16 |
Legacy Summary#
summary
FDA Review#
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