510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861564Substantially Equivalent

The Lung Gym (Xlator and Nlator)

El-Fax Company, Inc., Ardmore PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861564 is the FDA 510(k) clearance record for THE LUNG GYM (XLATOR AND NLATOR), a class II device, cleared for El-Fax Company, Inc. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for El-Fax Company, Inc. As of , FDA records show no recalls naming K861564.

Clearance record

Decision date
Received
(104 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
El-Fax Company, Inc. Box 407, Ardmore PA
Third party review
No

Clearances, product code BWF

Trailing 12 months

FDA records hold no clearances under product code BWF in the trailing twelve months.

FDA records show no clearances under product code BWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260