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FDA 510(k)

Respiratory Muscle Trainer

K-Number: K240959 · 2024-12-18

ApplicantChongqing Moffy Innovation Technology Co., Ltd.
Decision Date2024-12-18
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiratory Muscle Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Moffy Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K240959. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respiratory Muscle Trainer?

Respiratory Muscle Trainer is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Chongqing Moffy Innovation Technology Co., Ltd.. The 510(k) number is K240959.

When did Respiratory Muscle Trainer receive FDA 510(k) clearance?

Respiratory Muscle Trainer received FDA 510(k) clearance on 2024-12-18, under 510(k) number K240959.

Who is the listed applicant for Respiratory Muscle Trainer?

The FDA 510(k) record lists Chongqing Moffy Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respiratory Muscle Trainer?

The FDA product code for Respiratory Muscle Trainer is BYI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06958666Effectiveness of DITM Versus IMT in COPD PatientsRECRUITINGNCT07508332Lung Boost Trainer Versus Incentive Spirometer in Post COVID-19 Hemiplegic CP ChildrenCOMPLETED

Other records listing Chongqing Moffy Innovation Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241338Peak Flow Meter

Related Devices (Code: BYI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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