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Foot Extension MTIL3006002

by Medtec LLC

Ref MTIL3006002

Foot Extension MTIL3006002 is a device classified as Class I in the EU and Class II in the US made by Medtec LLC, registered in EUDAMED on 22 Apr 2025 (Basic UDI-DI 8414391OC0007R01B6), cleared under FDA 510(k) K973842 on 5 Dec 1997 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439104514), active as of 22 Oct 2026. 7 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

7 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K973842

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0007R01B6 Basic UDI-DI 00841439104514UDI-DIDate22 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439104514 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK973842 Date5 Dec 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0007R01B6 registered 22 Apr 2025 Active
  • FDA 510(k) K973842 decided 5 Dec 1997 Active
  • FDA GUDID UDI-DI 00841439104514 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

10 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 00841439104514
  10. Registered EUDAMED 8414391OC0007R01B6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Foot Extension
Generic name
Indexed-immobilization patient positioning system
Device name
Couchtop
Model / Ref / Catalog
MTIL3006002
Primary DI / UDI-DI
00841439104514
Basic UDI-DI
8414391OC0007R01B6
510(k) Number
FDA product code
IXQ
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Indexed-immobilization patient positioning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Width — 18 Inch
Length — 36 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)