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Vectra Epr System and Intelect Epr System

by Chattanooga Group

510(k) K031077

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031077 Date11 Dec 2003ClearedStatusActive

Recalls

17 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1637-2008 FDA Unclassified (pre-2012) initiated 28 Feb 2008
    • Terminated Z-1638-2008 FDA Unclassified (pre-2012) initiated 28 Feb 2008

    Device may fail to administer therapy during use.

  • 14 recalls, same reason

    • Terminated Z-1218-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1226-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1223-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1232-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1228-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1225-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1230-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1219-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1222-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1220-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1221-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1229-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1227-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077
    • Terminated Z-1231-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077

    Device malfunction: causing electric shock and burn.

    • Terminated Z-1224-2008 FDA Unclassified (pre-2012) initiated 17 Dec 2007 on shared 510(k) K031077

    Devices have the potential to electric shock and burn

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IMG
Device Class
Class II
Regulation
21 CFR Part 890.5860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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