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MagPro Accessories

by Tonica Elektronik A/S 3 variants

MagPro Accessories (9016E4581) is a magnetic neural stimulation system (FDA Class II; FDA product code GWF, Stimulator, Electrical, Evoked Response) made by Tonica Elektronik A/S, cleared under FDA 510(k) K061645 on 31 Oct 2006 and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 05713484030726), active as of 21 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K061645

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713484030726 UDI-DI Date28 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061645 Date31 Oct 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061645 decided 31 Oct 2006 Active
  • FDA GUDID UDI-DI 05713484030726 listed 28 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061645
  2. Listed FDA GUDID 05713484030726

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Magnetic neural stimulation system
Model / Ref / Catalog
Cable Splitter Ext. Trig for MagPro slave and Keypoint, 9016E4581
Primary DI / UDI-DI
05713484030726
510(k) Number
FDA product code
GWF
GMDN term
Magnetic neural stimulation system
Device class
Class II
Regulation number
882.1870
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Other devices filed under Magnetic neural stimulation system.

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Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)