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IPPS™ Overlay MTIL6022

by Medtec LLC

IPPS™ Overlay MTIL6022 is a Class II device made by Medtec LLC, cleared under FDA 510(k) K973842 on 5 Dec 1997 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439105306), active as of 22 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

510(k) K973842

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841439105306 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973842 Date5 Dec 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973842 decided 5 Dec 1997 Active
  • FDA GUDID UDI-DI 00841439105306 listed 2 Aug 2017 Listed

Recalls

7 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-3021-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010
    • Terminated Z-3020-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010
    • Terminated Z-3019-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010

    Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.

  • 3 recalls, same reason

    • Terminated Z-0396-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010
    • Terminated Z-0395-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010
    • Terminated Z-0394-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010

    Under certain conditions, the extensions can become detached from the main body of the couch.

    • Terminated Z-1721-2009 FDA Unclassified (pre-2012) initiated 6 Mar 2009

    The silkscreened indexing scale was reversed.

Timeline

9 dated events

  1. Cleared FDA 510(k) K973842
  2. Recall initiated FDA recalls Z-1721-2009
  3. Recall initiated FDA recalls Z-0396-2011
  4. Recall initiated FDA recalls Z-0395-2011
  5. Recall initiated FDA recalls Z-0394-2011
  6. Recall initiated FDA recalls Z-3021-2011
  7. Recall initiated FDA recalls Z-3020-2011
  8. Recall initiated FDA recalls Z-3019-2011
  9. Listed FDA GUDID 00841439105306

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IPPS™ Overlay
Generic name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
MTIL6022
Primary DI / UDI-DI
00841439105306
510(k) Number
FDA product code
IXQ
GMDN term
Indexed-immobilization patient positioning system
Device class
Class II
Regulation number
892.1980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indexed-immobilization patient positioning system

Cleared under the same submission (K973842)

and 8 more cleared under K973842

Similar devices in this category

Other devices filed under Indexed-immobilization patient positioning system.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)