510(k) K060735
K060735 is an FDA 510(k) premarket notification submitted by Axiom Worldwide, Inc. for the device "DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 26, 2006. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Axiom Worldwide, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2006
- Date Received
- March 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type