ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR
FDA premarket approval P910066/S014 · decided 2000-03-09
Approval details
- PMA number
- P910066
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2000-02-15
- Decision date
- 2000-03-09
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- Approval for revisions to the Physician Manual and Package Insert, and the Patient Manual.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Compex Sport Elite 3.0 (K201653) | Djo, LLC | 2020-11-27 |
| Compex Sport Elite (K170918) | Djo, LLC | 2017-06-20 |
| Compex Wireless USA (K170903) | Djo, LLC | 2017-06-19 |
| Strive (K153704) | Djo, LLC | 2016-06-03 |
| Chattanooga Revolution Wireless (K153696) | Djo, LLC | 2016-04-14 |
| VitalStim(R) Plus Electrotherapy System (K153224) | Djo, LLC | 2016-02-17 |
| Compex Wireless USA (K143551) | Djo, LLC | 2015-04-28 |
| VECTRA NEO CLINICAL THERAPY SYSTEM (K132284) | Djo, LLC | 2014-04-10 |