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MagPro Accessories

by Tonica Elektronik A/S 3 variants

MagPro Accessories (9016B0641) is a Class II device made by Tonica Elektronik A/S, cleared under FDA 510(k) K150641 on 31 Jul 2015 (1 earlier submission) and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 05713484031068), 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

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713484031068 UDI-DI Date28 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150641 Date31 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150641 decided 31 Jul 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713484031068 listed 28 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K061645
  2. Cleared FDA 510(k) K150641
  3. Listed FDA GUDID 05713484031068

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  • Withdrawn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
Markning acc. MCF/B-70 Clips-on, Left 5.5 cm, 9016B0641
Primary DI / UDI-DI
05713484031068
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

Similar devices in this category

Other devices filed under Magnetic neural stimulation system.

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Properties

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