Identity
- Trade Name
- EMS FDA UDI
- Generic Name
- Deep-tissue electromagnetic stimulation system, home-use FDA UDI
- Device Name
- MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as the abdomen, thighs, and buttocks with preset intensity protocols. FDA UDI
- Model / Reference
- MagnaCore FDA UDI
- Description
- MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as the abdomen, thighs, and buttocks with preset intensity protocols. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00199284910331 FDA UDI
- 510(k) Number
- K241601 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Deep-tissue electromagnetic stimulation system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Deep-tissue electromagnetic stimulation system, home-use
Ems by Canadian Pioneer Medical Technology Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Canadian Pioneer Medical Technology Corporation
Sources (1)
- FDA UDI ee80a218-7183-44ed-a6dd-dc956a1bc80b 34 fields · synced May 30, 2026