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Care Pal, Model CPW-10X

by Digio2 International Co., Ltd. 510(k)

Active United States

510(k) K091430

Overview

The Care Pal, Model CPW-10X is a transmitter and receiver for physiological signals using radiofrequency technology, classified under product code DRG and regulation number 870.2910. It is a cardiovascular device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to support patient management. It was cleared by the FDA on August 21, 2009, under K091430, and is manufactured by Digio2 International Co., Ltd. in Flagstaff, Arizona.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091430 Date21 Aug 2009ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Digio2 International Co., Ltd.

Questions

  • What is the Care Pal CPW-10X used for?

    The Care Pal CPW-10X is indicated for use in non-clinical settings to collect and transmit historical medical information from physiological signals to healthcare professionals to support patient management.

  • How does the Care Pal CPW-10X transmit data?

    The device uses radiofrequency technology to transmit physiological signals as a transmitter and receiver system, enabling data transfer from the patient to healthcare providers.

  • Is the Care Pal CPW-10X intended for clinical or non-clinical use?

    The device is specifically indicated for use in non-clinical settings, such as home or remote environments, to collect and transmit patient data to healthcare professionals.

  • What regulatory pathway was used for the Care Pal CPW-10X?

    The Care Pal CPW-10X received FDA 510(k) clearance as substantially equivalent to a predicate device under product code DRG and regulation number 870.2910.

  • Who manufactures the Care Pal CPW-10X and where is it made?

    The Care Pal CPW-10X is manufactured by Digio2 International Co., Ltd. in Flagstaff, Arizona, United States.