OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS
FDA premarket approval P910066/S020 · decided 2005-04-13
Approval details
- PMA number
- P910066
- Supplement
- S020
- 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 BROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2004-09-03
- Decision date
- 2005-04-13
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DJ ORTHOPEDICS, LLC, VISTA, CALIFORNIA.
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|---|---|---|
| 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 |