Ultrasonic Therapy Apparatus 407

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781317 ↗

FDA Product Code

IMI

Device Class

Class II

Regulation

21 CFR Part 890.5300

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Therapy Unit & Electrodiag.

  Class II

  FDA 510(k) K781314 Active Cleared 3 Oct 1978

• Shortwave Therapy Appar. Curamed 401

  Class II

  FDA 510(k) K781320 Active Cleared 27 Sep 1978

• Therapy Appar. 422 Interferential

  Class II

  FDA 510(k) K781319 Active Cleared 3 Oct 1978

• Pulsed and Continuous Shortwave Appar.

  Class II

  FDA 510(k) K781316 Active Cleared 27 Sep 1978

• Muscle Stimulation Apparatus

  Class II

  FDA 510(k) K781315 Active Cleared 3 Oct 1978

• Dynatron 406 Electrotherapy Apparatus

  Class II

  FDA 510(k) K781318 Active Cleared 3 Oct 1978

• What is the Ultrasonic Therapy Apparatus 407 used for?

  The Ultrasonic Therapy Apparatus 407 is designed to apply therapeutic deep heat to tissues using ultrasonic waves. This modality promotes tissue healing, reduces inflammation, and alleviates pain, making it particularly useful for musculoskeletal and soft tissue conditions in physical medicine settings.

• Is the Ultrasonic Therapy Apparatus 407 single-use or reusable?

  This device is not single-use—it is classified as a reusable medical instrument. Proper maintenance and adherence to manufacturer guidelines are required to ensure functionality and sterility over repeated clinical use.

• What regulatory clearance does the Ultrasonic Therapy Apparatus 407 hold?

  The device holds FDA 510(k) clearance under the reference number K781317, with a decision classification of *Substantially Equivalent* to a predicate device. It falls under FDA regulation 890.5300 and is intended for use in clinical settings by trained professionals.

• How should the Ultrasonic Therapy Apparatus 407 be stored?

  While storage instructions are not explicitly detailed in the provided data, reusable medical devices like this typically require clean, dry conditions away from direct sunlight or extreme temperatures. Follow the manufacturer’s maintenance guidelines to preserve functionality and sterility between uses.

• Does the Ultrasonic Therapy Apparatus 407 have any MRI safety information?

  The available data does not specify MRI safety information for this device. Clinicians should verify compatibility with their facility’s MRI protocols before use in environments with magnetic resonance imaging equipment.