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FDA 510(k)

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

K-Number: K233070 · 2024-03-13

ApplicantChongqing Rob Linka Science and Technology Co., Ltd.
Decision Date2024-03-13
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is a medical device manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-13 under approval number K233070. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233070.

When was Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) approved by the FDA?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) received FDA 510(k) clearance on 2024-03-13, under approval number K233070.

What company makes Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd..

What is the FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is NGX.

Related Clinical Trials

NCT07108231 Inspiratory Muscle Training in Hospitalized Heart Failure Patients RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07605117 Isoinertial Training in Patients With COPD RECRUITING NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT07610447 VR vs Treadmill Exercise in Children With Asthma RECRUITING

Related PubMed Literature

PMID: 40884106 Biosensor-embedded wearables for dry eye monitoring and management. Expert review of medical devices (2025)

Other Devices by Chongqing Rob Linka Science and Technology Co., Ltd.

K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable) K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116) K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

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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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