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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 the device name listed in this FDA 510(k) record. The listed applicant is Plexus Yoga, LLC Dba Chirp. It received FDA 510(k) clearance on 2024-06-27 under 510(k) 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. The listed applicant is Plexus Yoga, LLC Dba Chirp. The 510(k) number is K241509.

When did TENS&EMS units (SM9109A, SM9109B) receive FDA 510(k) clearance?

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

Who is the listed applicant for TENS&EMS units (SM9109A, SM9109B)?

The FDA 510(k) record lists Plexus Yoga, LLC Dba Chirp as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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