EXTENTRAC ELITE
FDA 510(k) clearance K031996 · decided 2004-07-23
Clearance details
- K-number
- K031996
- Device name
- EXTENTRAC ELITE
- Applicant
- Advanced Back Technologies
- Decision
- Substantially Equivalent
- Date received
- 2003-06-27
- Decision date
- 2004-07-23
- Days to decision
- 392 days
- Clearance type
- Abbreviated
- Product code
- ITH
- Device class
- 2
- Regulation number
- 890.5900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Syosset, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for tra recall (Z-1717-2015) | Advanced Back Technologies, Inc. | 2015-06-05 |
| Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction) recall (Z-1718-2015) | Advanced Back Technologies, Inc. | 2015-06-05 |