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FDA 510(k)

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

K-Number: K233092 · 2024-02-12

ApplicantChongqing Rob Linka Science and Technology Co., Ltd.
Decision Date2024-02-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) 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 2024-02-12 under 510(k) number K233092. 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 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233092.

When did Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) receive FDA 510(k) clearance?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233092.

Who is the listed applicant for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

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 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

The FDA product code for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is NUH.

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.

K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

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

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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