OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
FDA premarket approval P910066/S026 · decided 2012-08-10
Approval details
- PMA number
- P910066
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2012-05-09
- Decision date
- 2012-08-10
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE AND ACCEPTANCE ACTIVITIES LOCATED IN VISTA, CALIFORNIA
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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 |