FDA UDI
In Commercial Distribution
🇺🇸 United States
MedX Rehab Console System
DI: 00628451918158
·
Model: 3116
·
MedX Health Corp
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- MedX Rehab Console System
- Primary DI
- 00628451918158
- Version / Model
- 3116
- Company Name
- MedX Health Corp
- Labeler DUNS
- 202128257
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 10
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- e0e8a338-475c-44ab-a838-97b2da9e2fe3
Device Description
The MedX Rehab Console System is a therapeutic 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 MBM1100N Console powers the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for "hands-free" unattended treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60409 | Musculoskeletal/physical therapy laser, professional | An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00628451918103 | GS1 | ||||
| Primary | 00628451918158 | GS1 | ||||
| Package | 30628451918159 | GS1 | brown carton box | 3 | In Commercial Distribution | |
| Package | 50628451918153 | GS1 | shipping carton box | 5 | In Commercial Distribution | |
| Package | 20628451918152 | GS1 | shipping carton box | 2 | In Commercial Distribution | |
| Package | 40628451918156 | GS1 | shipping carton box | 4 | Not in Commercial Distribution | 2019-02-27 |
Customer Contacts
- Phone
- 1 905 670 4428
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032231 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 149 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit