ORTHOSONIX ENERGEX
FDA 510(k) clearance K013094 · decided 2001-12-14
Clearance details
- K-number
- K013094
- Device name
- ORTHOSONIX ENERGEX
- Applicant
- Orthosonix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-17
- Decision date
- 2001-12-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- NHH
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENERGEX (K042686) | Energex Systems, Inc. | 2005-06-16 |
Recalls involving this device
No recalls on record reference this clearance.