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FDA 510(k)

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

K-Number: K182136 · 2019-10-10

ApplicantShenzhen Osto Technology Co., Ltd.
Decision Date2019-10-10
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) 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 2019-10-10 under 510(k) number K182136. 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 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K182136.

When did Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) receive FDA 510(k) clearance?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) received FDA 510(k) clearance on 2019-10-10, under 510(k) number K182136.

Who is the listed applicant for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

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 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

The FDA product code for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) 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.

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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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