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FDA 510(k)

TENS&EMS units (SM9109A, SM9109B)

K-Number: K241509 · 2024-06-27

ApplicantPlexus Yoga, LLC Dba Chirp
Decision Date2024-06-27
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS&EMS units (SM9109A, SM9109B) is a medical device manufactured by Plexus Yoga, LLC Dba Chirp. It received FDA 510(k) clearance on 2024-06-27 under approval number K241509. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS&EMS units (SM9109A, SM9109B)?

TENS&EMS units (SM9109A, SM9109B) is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Plexus Yoga, LLC Dba Chirp. The 510(k) number is K241509.

When was TENS&EMS units (SM9109A, SM9109B) approved by the FDA?

TENS&EMS units (SM9109A, SM9109B) received FDA 510(k) clearance on 2024-06-27, under approval number K241509.

What company makes TENS&EMS units (SM9109A, SM9109B)?

TENS&EMS units (SM9109A, SM9109B) is manufactured by Plexus Yoga, LLC Dba Chirp.

What is the FDA product code for TENS&EMS units (SM9109A, SM9109B)?

The FDA product code for TENS&EMS units (SM9109A, SM9109B) is NUH.

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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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