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FDA 510(k)

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H

K-Number: K210756 · 2021-06-11

ApplicantShenzhen Osto Technology Company Limited
Decision Date2021-06-11
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210756. 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: AST-905A, AST-905D, AST-905H?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K210756.

When did Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H receive FDA 510(k) clearance?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210756.

Who is the listed applicant for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

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

What is the FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

The FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is NUH.

Other records listing Shenzhen Osto Technology Company Limited 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 MaskK211942Heating 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)K190783Health Expert Electronic Stimulator (model: AST-300L)K190673Health Expert Electronic Stimulator

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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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