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Positioning Cushion 301005BLK

by Medtec LLC

Positioning Cushion 301005BLK is a Class II device made by Medtec LLC, cleared under FDA 510(k) K060737 on 31 Mar 2006 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439102251), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K060737

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 Number00841439102251 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060737 Date31 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060737 decided 31 Mar 2006 Active
  • FDA GUDID UDI-DI 00841439102251 listed 2 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060737
  2. Listed FDA GUDID 00841439102251

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Positioning Cushion
Generic name
Radiological headrest
Model / Ref / Catalog
301005BLK
Primary DI / UDI-DI
00841439102251
510(k) Number
FDA product code
IYE
GMDN term
Radiological headrest
Device class
Class II
Regulation number
892.5050
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Size
Length — 9.13 Inch

From the manufacturer

Manufacturer's product page: Vacuum & Positioning Cushions

Related devices

Cleared under the same submission (K060737)

and 8 more cleared under K060737

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)