Diter Ultrasonic S 3000
by Diter Elektroniikka OY 510(k)
Active
510(k) K901950
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901950 | Date27 Jul 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5300
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Diter Ultrasonic S 3000 is an Ultrasonic Diathermy Device designed for applying therapeutic deep heat. It operates using ultrasonic energy to promote tissue healing, reduce inflammation, and alleviate pain in targeted areas through controlled thermal effects. This modality is commonly employed in physical medicine for musculoskeletal and soft tissue conditions. The device delivers focused ultrasound waves to penetrate deep tissues, enhancing circulation and metabolic activity at the application site.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as physical therapy clinics, rehabilitation centers, and outpatient care facilities. It is classified under FDA regulation 890.5300 and has received FDA 510(k) clearance (K901950) as substantially equivalent to a predicate device. The device’s operation does not involve MRI compatibility concerns, and its specifications align with traditional ultrasonic diathermy standards. Storage and maintenance instructions are manufacturer-specific but typically require adherence to standard electrical and hygiene protocols for reusable medical equipment.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Diter Ultrasonic S 3000?
The Diter Ultrasonic S 3000 is designed for applying therapeutic deep heat using ultrasonic energy. It promotes tissue healing, reduces inflammation, and alleviates pain in targeted areas, particularly for musculoskeletal and soft tissue conditions. This modality enhances circulation and metabolic activity at the application site, making it ideal for physical medicine applications in clinical settings like physical therapy clinics or rehabilitation centers.
Is the Diter Ultrasonic S 3000 a single-use or reusable device?
The Diter Ultrasonic S 3000 is a reusable medical instrument. As such, it requires proper maintenance and adherence to standard electrical and hygiene protocols to ensure safe and effective use across multiple treatments. Reusability extends its utility in clinical environments where multiple patients may benefit from its therapeutic effects.
What regulatory clearance does the Diter Ultrasonic S 3000 hold?
The Diter Ultrasonic S 3000 has received FDA 510(k) clearance under the classification 890.5300, with the clearance number K901950. This classification confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use for therapeutic deep heat applications.
Does the Diter Ultrasonic S 3000 require special storage conditions?
While specific storage instructions are manufacturer-provided, reusable ultrasonic diathermy devices like the Diter Ultrasonic S 3000 generally require protection from physical damage, moisture, and extreme temperatures. Standard electrical safety protocols should be followed, and the device should be stored in a clean, dry environment to maintain its functionality and hygiene for repeated use in clinical settings.
Is the Diter Ultrasonic S 3000 MRI-compatible?
The Diter Ultrasonic S 3000 does not present MRI compatibility concerns. This means it can be safely used in environments where MRI scans are conducted without interfering with magnetic resonance imaging systems, making it versatile for integrated clinical settings where both modalities may be employed.