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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 the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-13 under 510(k) 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. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233070.

When did Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) receive FDA 510(k) clearance?

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

Who is the listed applicant for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

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Other records listing Chongqing Rob Linka Science and Technology Co., Ltd. as applicant

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.

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Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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