EMS MagnaCore
by Canadian Pioneer Medical Technology Corporation
EMS MagnaCore is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Canadian Pioneer Medical Technology Corporation, cleared under FDA 510(k) K241601 on 25 Feb 2025 and listed in FDA GUDID since 30 Jun 2025 (UDI-DI 00199284910331), active as of 23 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 | Number00199284910331 | Date30 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241601 | Date25 Feb 2025 | StatusActive |
Official records
- AccessGUDID record 00199284910331
- FDA 510(k) database K241601
Across registries
- FDA 510(k) K241601 decided 25 Feb 2025 Active
- FDA GUDID UDI-DI 00199284910331 listed 30 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K241601
- Listed FDA GUDID 00199284910331
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ems
- Generic name
- Deep-tissue electromagnetic stimulation system, home-use
- Model / reference
- MagnaCore
- Primary DI / UDI-DI
- 00199284910331
- 510(k) Number
- FDA product code
- NGX
- GMDN term
- Deep-tissue electromagnetic stimulation system, home-use
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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