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FDA 510(k)

Low-frequency Multi-function physiotherapy instrument

K-Number: K172837 · 2018-11-26

ApplicantShenzhen Osto Technology Co., Ltd.
Decision Date2018-11-26
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Low-frequency Multi-function physiotherapy instrument is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K172837. 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 Low-frequency Multi-function physiotherapy instrument?

Low-frequency Multi-function physiotherapy instrument is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172837.

When did Low-frequency Multi-function physiotherapy instrument receive FDA 510(k) clearance?

Low-frequency Multi-function physiotherapy instrument received FDA 510(k) clearance on 2018-11-26, under 510(k) number K172837.

Who is the listed applicant for Low-frequency Multi-function physiotherapy instrument?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Low-frequency Multi-function physiotherapy instrument?

The FDA product code for Low-frequency Multi-function physiotherapy instrument is NUH.

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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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