FDA 510(k)

Neck Care Therapy, Model: SYK 509B

K-Number: K172897 · 2018-12-07

ApplicantShenzhen Osto Technology Co., Ltd.

Decision Date2018-12-07

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neck Care Therapy, Model: SYK 509B 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 2018-12-07 under 510(k) number K172897. 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 Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172897.

When did Neck Care Therapy, Model: SYK 509B receive FDA 510(k) clearance?

Neck Care Therapy, Model: SYK 509B received FDA 510(k) clearance on 2018-12-07, under 510(k) number K172897.

Who is the listed applicant for Neck Care Therapy, Model: SYK 509B?

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 Neck Care Therapy, Model: SYK 509B?

The FDA product code for Neck Care Therapy, Model: SYK 509B is NUH.

Other records listing Shenzhen Osto 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.

K213056LED Facial Mask K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)K212989Low-frequency Stimulator (Model: AST-645, AST-646)K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H K190783Health Expert Electronic Stimulator (model: AST-300L)

View all 11 devices →

Related Devices (Code: NUH)

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 Limited K251958VEINOPLUS 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.