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SmartLank Wireless, Model 001970

by Mrl, A Welch Allyn Company

510(k) K033642

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 NumberK033642 Date25 May 2004ClearedStatusActive

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  • Withdrawn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
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 SmartLank Wireless, Model 001970, is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. This device is intended for use by trained responders in emergency settings to provide life-saving intervention during cardiac emergencies.

Supplied as a reusable medical device, the SmartLank Wireless operates in non-MRI environments and is intended for single-patient use per cycle. It requires proper calibration and maintenance as outlined in manufacturer guidelines. The device holds an FDA 510(k) clearance under the classification of Class III, with regulatory oversight under 21 CFR 870.5310, and is distributed by Mrl, a Welch Allyn Company.

Questions

AI-generated answers, 18 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 SmartLank Wireless, Model 001970, primarily used for in emergency settings?

    The SmartLank Wireless, Model 001970, is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It is intended for use by trained responders in emergency situations to provide life-saving intervention during cardiac emergencies.

  • Is the SmartLank Wireless, Model 001970, a single-use or reusable device?

    The SmartLank Wireless, Model 001970, is a reusable medical device. However, it is intended for single-patient use per cycle, meaning it can be used repeatedly across different patients but must be properly calibrated and maintained between uses as outlined by the manufacturer.

  • Can the SmartLank Wireless, Model 001970, be used in an MRI environment?

    No, the SmartLank Wireless, Model 001970, is explicitly designed for use in non-MRI environments. It is not intended for use in areas where magnetic resonance imaging is conducted.

  • What regulatory pathway was followed for the FDA clearance of the SmartLank Wireless, Model 001970?

    The SmartLank Wireless, Model 001970, received FDA clearance through a 510(k) submission, classified as Substantially Equivalent under the Cardiovascular advisory committee. The device falls under Class III regulatory oversight, governed by 21 CFR 870.5310, and was reviewed via a traditional pathway.

  • Who is the manufacturer and distributor of the SmartLank Wireless, Model 001970?

    The SmartLank Wireless, Model 001970, is manufactured by Mrl, a Welch Allyn Company, and distributed by the same organization. The device’s regulatory filings are also attributed to Mrl, A Welch Allyn Company.