Identity
- Trade Name
- MedX Rehab Console System FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment. FDA UDI
- Model / Reference
- 3110 FDA UDI
- Description
- The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918127 FDA UDI
- 510(k) Number
- K032231 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
Yes
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
No
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
MedX Rehab Console System by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K032231 also covers:
- MedX Rehab Console System — MedX Health Corp
- MedX Rehab Console System — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX Rehab Tethered Laser — MedX Health Corp
- MedX SLD Light Cluster — MedX Health Corp
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
- MedX Health Corp
Sources (1)
- FDA UDI 719e1e63-a6eb-44d8-9fff-da7ffc8ccf7e 36 fields · synced Jun 1, 2026