510(k) K951244
K951244 is an FDA 510(k) premarket notification submitted by Dan Kline for the device "SPINE TUNER POSTURE TRAINER". The FDA issued a decision of Substantially Equivalent on June 26, 1995. The device falls under product code LZW (Monitor, Spine Curvature), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1995
- Date Received
- March 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Spine Curvature
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type