Identity
- Trade Name
- MedX Rehab Console System FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- The MedX Rehab 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, bruising, wound healing 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 MBM 1100N console powers the one (1) laser therapy device. FDA UDI
- Model / Reference
- 3114 FDA UDI
- Description
- The MedX Rehab 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, bruising, wound healing 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 MBM 1100N console powers the one (1) laser therapy device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918141 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 641e7f17-42a5-41a6-9bb1-37a25ce5f2f7 36 fields · synced Jun 8, 2026