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Nice1 Powered Inflatable Massager

by Nice Recovery Systems, LLC

510(k) K143197

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143197↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK143197 Date23 Dec 2014ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Nice1
510(k) Number
FDA Product Code
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
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 Nice1 is a Powered Inflatable Tube Massager, designed to provide intermittent pneumatic compression for therapeutic applications in physical medicine. It delivers controlled air pressure to promote circulation, reduce edema, and enhance tissue healing through sequential inflation and deflation of inflatable tubes.

This device is intended for clinical use in physical medicine settings and is supplied as a reusable system requiring proper cleaning and maintenance. It operates with an air pump and control unit, with multiple tube sizes available for different patient applications. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization. Sterility is not applicable, as the device is not single-use.

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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 Nice1 primarily used for in clinical settings?

    The Nice1 is a Powered Inflatable Tube Massager designed for intermittent pneumatic compression in physical medicine. It helps promote circulation, reduce swelling (edema), and support tissue healing by sequentially inflating and deflating inflatable tubes around a patient’s limbs or affected areas.

  • Is the Nice1 a single-use device, or can it be reused after cleaning?

    The Nice1 is a reusable system, not intended for single-use. Proper cleaning and maintenance are required to ensure safe and effective operation over multiple uses, as outlined in the manufacturer’s instructions.

  • What types of tube sizes are available for the Nice1, and how do they differ?

    The Nice1 comes with multiple tube sizes, each designed for different patient applications. While the exact dimensions are not specified here, the variety allows for customization to fit various limb circumferences or treatment areas, ensuring optimal compression therapy.

  • How is the Nice1 regulated, and what does that mean for its use?

    The Nice1 has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for Class II medical devices. This classification means it undergoes rigorous review to ensure safety and effectiveness for its intended use in physical medicine, though it does not imply any specific clinical indication beyond what’s described.

  • Does the Nice1 require special storage conditions, and is it sterile?

    The Nice1 is not sterile, as it is a reusable device. Storage should follow manufacturer guidelines to maintain cleanliness and functionality, typically involving protection from moisture, dust, and physical damage. Sterility is not applicable due to its reusable design.