Identity
- Trade Name
- OrthoCor Medical FDA UDI
- Generic Name
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
- Device Name
- The Active System is a portable, compact, light-weight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and thermal exchange therapy for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis. FDA UDI
- Model / Reference
- Active System Elbow FDA UDI
- Description
- The Active System is a portable, compact, light-weight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and thermal exchange therapy for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851979007428 FDA UDI
- 510(k) Number
- K241395 FDA UDI
- FDA Product Code
- ILX FDA UDIIMD FDA UDI
- GMDN Term
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 FDA UDI890.5710 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Hand-held deep-tissue electromagnetic stimulator
OrthoCor Medical by Caerus Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K241395 also covers:
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Caerus Corporation
Sources (1)
- FDA UDI 8a3abcfa-5b50-47ee-90e3-42ea41c86672 34 fields · synced Jun 8, 2026