FDA 510(k)

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

N.º K: K211942 · 2021-12-13

SolicitanteShenzhen Osto Technology Company Limited

Fecha de decisión2021-12-13

Código de productoNGX

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Fuente oficial

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