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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 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 2021-12-13 under 510(k) 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. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K211942.

When did Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

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 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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Related Devices (Code: NGX)

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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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