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FDA 510(k)

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

K-Number: K242430 · 2024-11-12

ApplicantSoul Mobility
Decision Date2024-11-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Soul Mobility. The 510(k) number is K242430.

When was Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) approved by the FDA?

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

What company makes Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is manufactured by Soul Mobility.

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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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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