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A-V Impulse System Model 6060

by Novamedix, Ltd. 2 variants

510(k) K951683

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK951683 Date26 Oct 1995ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2657-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2010
    • Terminated Z-2656-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2010

    Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any

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  • Withdrawn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
JOW
FDA applicant
Novamedix , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 A-V Impulse System Model 6060 is a sleeve, limb, compressible device used in cardiovascular applications. It is designed to provide impulse therapy for limbs, likely through compression or stimulation mechanisms.

The device is supplied by Novamedix, Ltd. and has received FDA 510(k) clearance with the product code JOW. It is classified as a Class II medical device and is regulated under section 870.5800. The system is available in various sizes as indicated by the multiple registration numbers provided.

Other devices from Novamedix, Ltd.

Questions

AI-generated answers, 24 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 A-V Impulse System Model 6060 used for?

    The A-V Impulse System Model 6060 is a sleeve, limb, compressible device used in cardiovascular applications to provide impulse therapy for limbs through compression or stimulation mechanisms.

  • How is the A-V Impulse System Model 6060 supplied?

    The device is supplied by Novamedix, Ltd. and is available in various sizes as indicated by the multiple registration numbers provided.

  • What is the regulatory status of the A-V Impulse System Model 6060?

    The A-V Impulse System Model 6060 has received FDA 510(k) clearance with the product code JOW. It is classified as a Class II medical device and is regulated under section 870.5800.

  • Is the A-V Impulse System Model 6060 reusable or single-use?

    The device data does not specify whether the A-V Impulse System Model 6060 is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.