FDA 510(k)

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)

Número K: K242430 · 2024-11-12

Data da decisão2024-11-12

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is the device name listed in this FDA 510(k) record. The listed applicant is Soul Mobility. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242430. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Soul Mobility. The 510(k) number is K242430.

When did Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) receive FDA 510(k) clearance?

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242430.

Who is the listed applicant for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

The FDA 510(k) record lists Soul Mobility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

The FDA product code for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is ITI.

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