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QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS - CO1A

by United Pacific Co., Ltd.

510(k) K993123

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993123 Date17 Dec 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Models / Variants
CO1A
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The QK-Wide Band Spectrum Therapeutic Apparatus is a physical medicine device available in models CO1A, CO1B, CO1C, CO1D, CO2A, and CO2B. It is designed for therapeutic applications utilizing a wide band spectrum technology.

This device is supplied by United Pacific Co., Ltd. and has received FDA 510(k) clearance with decision code SESE. It is intended for use in physical medicine settings, though specific sterility, single-use or reusable status, MRI safety, and storage details are not provided in the available data.

Other devices from United Pacific Co., Ltd.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.