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FDA 510(k)

EnergyLounger (TY-01)

K-Number: K241947 · 2025-03-03

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-03-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EnergyLounger (TY-01) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-03-03 under approval number K241947. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnergyLounger (TY-01)?

EnergyLounger (TY-01) is a medical device that received FDA 510(k) clearance on 2025-03-03. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K241947.

When was EnergyLounger (TY-01) approved by the FDA?

EnergyLounger (TY-01) received FDA 510(k) clearance on 2025-03-03, under approval number K241947.

What company makes EnergyLounger (TY-01)?

EnergyLounger (TY-01) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for EnergyLounger (TY-01)?

The FDA product code for EnergyLounger (TY-01) is OHS.

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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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