FDA 510(k)

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

K-Number: K211942 · 2021-12-13

ApplicantShenzhen Osto Technology Company Limited

Decision Date2021-12-13

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is a medical device manufactured by Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2021-12-13 under approval number K211942. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Shenzhen Osto Technology Company Limited. The 510(k) number is K211942.

When was Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) approved by the FDA?

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) received FDA 510(k) clearance on 2021-12-13, under approval number K211942.

What company makes Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is manufactured by Shenzhen Osto Technology Company Limited.

What is the FDA product code for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

The FDA product code for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is NGX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.