FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Hi D US
DI: 08033765391740
·
Model: F9000303
·
ASA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M-Hi D US
- Primary DI
- 08033765391740
- Version / Model
- F9000303
- Company Name
- ASA SRL
- Labeler DUNS
- 429533573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-10
- Public Version
- 2
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 8d9e4cf4-7915-49f8-9c2d-7eb89d945673
Device Description
The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 35147 | Musculoskeletal infrared phototherapy unit, non-wearable | An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033765391740 | GS1 |