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MagPro Accessories Trolley for MagPro R20

by Tonica Elektronik A/S

MagPro Accessories Trolley for MagPro R20 (9016B0381) is a Class II device made by Tonica Elektronik A/S, cleared under FDA 510(k) K170114 on 1 May 2017 (1 earlier submission) and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 05713484030238), active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713484030238 UDI-DI Date28 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170114 Date1 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170114 decided 1 May 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713484030238 listed 28 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160280
  2. Cleared FDA 510(k) K170114
  3. Listed FDA GUDID 05713484030238

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MagPro Accessories
Generic name
Magnetic neural stimulation system
Model / Ref / Catalog
Trolley for MagPro R20, 9016B0381
Primary DI / UDI-DI
05713484030238
510(k) Number
FDA product code
OBP, GWF
GMDN term
Magnetic neural stimulation system
Device class
Class II
Regulation number
882.5805, 882.1870
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

  • Manufacturing date
Other properties (14, all answered No)