Extentrac Elite
510(k) K031996
Extentrac Elite is a Class II device made by Advanced Back Technologies, cleared under FDA 510(k) K031996 on 23 Jul 2004, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031996 | Date23 Jul 2004 | StatusActive |
Official records
- FDA 510(k) database K031996
Recalls
-
- Terminated Z-1717-2015
- Terminated Z-1718-2015
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Timeline
- Cleared FDA 510(k) K031996
- Recall initiated FDA recalls Z-1717-2015
- Recall initiated FDA recalls Z-1718-2015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITH
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K031996
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Extentrac Elite M100 | M100 | B727M100 | — | On the market |
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