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MagPro Accessories Markning acc., B65 Clips-on- Left 5.5cm

by Tonica Elektronik A/S

MagPro Accessories Markning acc., B65 Clips-on- Left 5.5cm (9016B0571) is a Class II device made by Tonica Elektronik A/S, cleared under FDA 510(k) K170114 on 1 May 2017 and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 05713484030979), 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

510(k) K170114

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 Number05713484030979 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
  • FDA GUDID UDI-DI 05713484030979 listed 28 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170114
  2. Listed FDA GUDID 05713484030979

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  • Withdrawn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
Markning acc., B65 Clips-on- Left 5.5cm, 9016B0571
Primary DI / UDI-DI
05713484030979
510(k) Number
FDA product code
OBP
GMDN term
Magnetic neural stimulation system
Device class
Class II
Regulation number
882.5805
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

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