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Air Smart Extra Spirometer

by Feellife Health Inc.

510(k) K222443

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

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) K222443↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222443 Date9 Aug 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222443 decided 9 Aug 2023 Active
  • EUDAMED Active· +1 more in the status table

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
BZG
FDA applicant
Feellife Health, Inc.
Device class
Class II
Regulation
21 CFR Part 868.1840
Advisory committee
Anesthesiology
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 AirSmart Extra Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function by assessing airflow and lung volumes. It evaluates parameters such as forced expiratory volume (FEV₁), forced vital capacity (FVC), and peak expiratory flow (PEF) to aid in the assessment of respiratory conditions.

This device is intended for use in clinical and home settings, supplied as a single-use or reusable unit depending on the configuration. It operates under regulatory authorisations including FDA 510K clearance, MDD, and MDR compliance, with a classification as a Class II medical device. Storage and usage adhere to manufacturer guidelines, ensuring accurate and reliable spirometry results for diagnostic purposes.

Devices cleared under K222443

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222443
UDI-DISize and differences
Spirometer Air Smart Extra
FEELLIFE HEALTH INC.
Air Smart Extra06934325302294 —On the market

Similar devices

Other devices filed under FDA product code BZG (Spirometer, Diagnostic).

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