OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE
FDA premarket approval P910066/S024 · decided 2007-12-10
Approval details
- PMA number
- P910066
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2007-10-12
- Decision date
- 2007-12-10
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR THE MODIFICATION OF THE EXISTING COIL GEOMETRY, THE ADDITION OF A WIRED CONTROL BOX, THE RECONFIGURATION OF THE PATIENT PADDING SYSTEM, AND THE REMOVAL OF THE INFRARED PATIENT COMPLIANCE COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.
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 |