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Wearable Device - Cradle

by Snap40, Ltd.

510(k) K182543

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 NumberK182543 Date14 Nov 2018ClearedStatusActive

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  • Withdrawn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
MSX
Models / Variants
Cradle
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The device is a wearable device system, including a cradle, straps in small, medium, and large sizes, a multiple device charger, and a hospital starter package. It is intended for use in cardiovascular applications, as indicated by its classification and advisory committee designation.

The device is supplied as part of a hospital starter package and includes a multiple device charger. It is regulated under FDA 510(k) clearance, with a decision of substantially equivalent. The device is not specified as single-use or reusable, and no specific storage or MRI safety information is provided.

Questions

AI-generated answers, 1 Oct 2026

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

  • What components are included in this device system?

    The system includes a wearable device cradle, straps in small, medium, and large sizes, a multiple device charger, and a hospital starter package.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance, with a decision of substantially equivalent.

  • What is the intended use of this device?

    The device is intended for use in cardiovascular applications.

  • Is the device single-use or reusable?

    The device is not specified as single-use or reusable.

  • What is the advisory committee designation for this device?

    The advisory committee designation is Cardiovascular.