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SpineMED Decompression System S200E

by Universal Pain Technology Canada Inc

SpineMED Decompression System S200E is a Class II device made by Universal Pain Technology Canada Inc, cleared under FDA 510(k) K051013 on 27 Apr 2005, registered in EUDAMED and listed in FDA GUDID since 30 Jun 2016 (UDI-DI M767S200E1), active as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051013

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberM767S200E1 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051013 Date27 Apr 2005DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K051013 decided 27 Apr 2005 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI M767S200E1 listed 30 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K051013
  2. Listed FDA GUDID M767S200E1

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  • Withdrawn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
SpineMED Decompression System
Generic name
Programmable powered traction system
Model / reference
S200E
Primary DI / UDI-DI
M767S200E1
510(k) Number
FDA product code
ITH
GMDN term
Programmable powered traction system
Device class
Class II
Regulation number
890.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Programmable powered traction system

Cleared under the same submission (K051013)

and 1 more cleared under K051013

Similar devices

Other devices filed under FDA product code ITH (Equipment, Traction, Powered).

Other devices from Universal Pain Technology Canada Inc

See all devices from Universal Pain Technology Canada Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)