AllPEP

FDA 510(k) K233855 · Enchant Tek Co. , Ltd.

Substantially Equivalent

510(k) numberK233855

Submission

Device name
AllPEP
Applicant
Enchant Tek Co. , Ltd.
Yilan County, TW
Received
December 5, 2023
Decision date
February 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BWF – Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Specialty
Anesthesiology

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K181660Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional Smiths Medical10/24/2019SE
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Questions and answers

When was AllPEP cleared by the FDA?

AllPEP (K233855) received a 510(k) decision of Substantially Equivalent on February 2, 2024, 59 days after the submission was received.

What is the product code of K233855?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.