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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 a medical device manufactured by Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-10 under approval 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. It is manufactured by Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K182136.

When was Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) approved by the FDA?

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

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

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is manufactured by Shenzhen Osto Technology Co., Ltd..

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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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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