MagPro Accessories Flow Am coil adapter kit, ø29-2pcs
MagPro Accessories Flow Am coil adapter kit, ø29-2pcs (9016B0841) is a Class II device made by Tonica Elektronik A/S, cleared under FDA 510(k) K193006 on 9 Aug 2020 (1 earlier submission) and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 05713484031303), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05713484031303 | Date28 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193006 | Date9 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 05713484031303
- FDA 510(k) database K193006
- FDA 510(k) database K061645
Across registries
- FDA 510(k) K193006 decided 9 Aug 2020 Active
- FDA GUDID UDI-DI 05713484031303 listed 28 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K061645
- Cleared FDA 510(k) K193006
- Listed FDA GUDID 05713484031303
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MagPro Accessories
- Generic name
- Magnetic neural stimulation system
- Model / Ref / Catalog
- Flow Am coil adapter kit, ø29-2pcs, 9016B0841
- Primary DI / UDI-DI
- 05713484031303
- FDA product code
- QCI, GWF
- GMDN term
- Magnetic neural stimulation system
- Device class
- Class II
- Regulation number
- 882.5802, 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.