ULTRASOUND THERAPY EQUIPMENT
Basic Information
- Primary DI
- 06266779400029
- Basic UDI-DI Code
- B-06266779400029
- Reference
- 4846
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
Additional Description
The "US 215M" is an ultrasound therapy device manufactured by NOVIN Electronics & Electrical Industries Engineering Co. and is part of the innovative Metrix series of products. This advanced device operates at two frequencies, 1 and 3 MHz, and delivers a maximum output power of 12 W. Notably, the US 215M can be connected to an electrotherapy device, enabling combination therapy. Combination therapy typically involves the simultaneous application of ultrasound (US) with electrical stimulation therapy. While Diadynamic Currents are frequently utilized in Europe, the UK often combines US with bipolar Interferential Therapy (IF). Ultrasound, commonly abbreviated as US, refers to sound waves that travel through various media at frequencies higher than the upper limit of human audibility, approximately 20 KHz. Sound is a form of mechanical acoustic energy, or pressure waves, which propagate through vibrations in the air and other media such as water and soft biological tissues. Therapeutic ultrasound harnesses this acoustic energy to treat a range of soft tissue pathologies. Conditions commonly treated with ultrasound include soft tissue injuries like tendonitis (or tendinitis), non-acute joint swelling, and muscle spasm. Most muscle and ligament injuries can benefit from therapeutic ultrasound.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120610 | ULTRASOUND THERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-358 | MTIC InterCert S.r.l. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).