QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS - CO1D

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

510(k) Number

K993123 ↗

FDA Product Code

ILY

Models / Variants

CO1A

CO1B

CO1C

CO1D

CO2A

CO2B

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• What is the QK-Wide Band Spectrum Therapeutic Apparatus used for?

  The QK-Wide Band Spectrum Therapeutic Apparatus is a physical medicine device designed for therapeutic applications utilizing wide band spectrum technology. It is intended for use in physical medicine settings, though specific clinical indications are not detailed in the available data.

• What models are available for the QK-Wide Band Spectrum Therapeutic Apparatus?

  The QK-Wide Band Spectrum Therapeutic Apparatus is available in six models: CO1A, CO1B, CO1C, CO1D, CO2A, and CO2B. Each model may have specific features or applications, though detailed specifications for each model are not provided in the available data.

• What regulatory clearance has the QK-Wide Band Spectrum Therapeutic Apparatus received?

  The QK-Wide Band Spectrum Therapeutic Apparatus has received FDA 510(k) clearance with decision code SESE (Substantially Equivalent) on December 17, 1999. The device was reviewed under the Physical Medicine advisory committee and has product code ILY.

• Is the QK-Wide Band Spectrum Therapeutic Apparatus single-use or reusable?

  The available data does not specify whether the QK-Wide Band Spectrum Therapeutic Apparatus is designed for single-use or multiple uses. Similarly, information regarding sterility status, MRI safety, and storage requirements is not provided in the device data.