510(k) K141399
K141399 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 2014. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Stimwave Technologies Incorporated has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2014
- Date Received
- May 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Spinal-Cord, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5880
- Review Panel
- NE
- Submission Type