FDA 510(k)

Massager de Compressão de Ar (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

Número K: K243206 · 2025-02-19

RequerenteSichuan Qianli-Beoka Medical Technology, Inc.

Data da decisão2025-02-19

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Qianli-Beoka Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243206. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)?

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Sichuan Qianli-Beoka Medical Technology, Inc.. The 510(k) number is K243206.

When did Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) receive FDA 510(k) clearance?

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243206.

Who is the listed applicant for Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)?

The FDA 510(k) record lists Sichuan Qianli-Beoka Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)?

The FDA product code for Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) is IRP.

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