Medco-Sonic NQ-2000

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

510(k) Number

K860099 ↗

FDA Product Code

IMI

Device Class

Class II

Regulation

21 CFR Part 890.5300

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Endoscopic Delivery System

  Class II

  FDA 510(k) K913172 Active Cleared 6 Sep 1991

• Medcolator Model Gx

  Class II

  FDA 510(k) K842712 Active Cleared 19 Sep 1984

• Rotary Vascular Knife

  Class I

  FDA 510(k) K822829 Active Cleared 17 Nov 1982

• Medchem Surgical Delivery System

  Class II

  FDA 510(k) K932466 Active Cleared 9 Aug 1993

• Jyrochair, Model Sk-H

  Class II

  FDA 510(k) K852015 Active Cleared 19 Jul 1985

• Medcolator Model Hvx

  Class II

  FDA 510(k) K844580 Active Cleared 25 Feb 1985

See all devices from Medco Products, Co., Inc. →

• What clinical applications is the Medco-Sonic NQ-2000 intended for, and how does it work?

  The Medco-Sonic NQ-2000 is designed for physical medicine applications to apply therapeutic deep heat to tissues using ultrasonic energy. It promotes tissue healing, reduces inflammation, and alleviates pain by delivering controlled ultrasonic waves, making it suitable for professional use in clinical settings like physical therapy or rehabilitation.

• Is the Medco-Sonic NQ-2000 a single-use or reusable device, and what does that mean for maintenance?

  The Medco-Sonic NQ-2000 is classified as a reusable medical instrument, meaning it is intended for repeated use in clinical settings under professional supervision. Since no specific storage or maintenance instructions are provided in the regulatory records, users should follow general guidelines for ultrasonic diathermy devices to ensure proper cleaning, calibration, and upkeep between uses.

• Can this device be used in an MRI environment, and what safety considerations should be noted?

  The Medco-Sonic NQ-2000 is explicitly not classified as MRI-safe or MRI-conditional, meaning it should not be used in or near an MRI scanner. Clinicians must ensure the device is removed from the patient and the treatment area before MRI procedures to avoid interference or safety risks.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use today?

  The Medco-Sonic NQ-2000 received FDA 510(k) clearance in 1986 under the product code IMI, with a decision of *Substantially Equivalent (SESE)* by the Physical Medicine Advisory Committee. This classification means it was deemed comparable to a legally marketed device at the time, and while it remains cleared, users should confirm compliance with current FDA guidelines for ultrasonic diathermy devices, as regulations may evolve.

• Are there different models or sizes available for the Medco-Sonic NQ-2000, and how would I determine the right one for my practice?

  The regulatory data does not specify multiple models or sizes for the Medco-Sonic NQ-2000, implying a single primary configuration. Since it is designed for general therapeutic deep heat applications in physical medicine, the choice depends on your practice’s specific patient needs and treatment protocols. Consulting the manufacturer’s historical documentation or contacting Medco Products directly may provide additional clarity on historical variations or accessories.