FDA 510(k)

BACK 3

Número K: K230037 · 2023-07-19

Data da decisão2023-07-19

Código do produtoPBX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BACK 3 is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K230037. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BACK 3?

BACK 3 is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Swims America Corp. The 510(k) number is K230037.

When did BACK 3 receive FDA 510(k) clearance?

BACK 3 received FDA 510(k) clearance on 2023-07-19, under 510(k) number K230037.

Who is the listed applicant for BACK 3?

The FDA 510(k) record lists Swims America Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BACK 3?

The FDA product code for BACK 3 is PBX.

Outros registros que listam Swims America Corp como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K230167BACK 4 K220014RSHOCK K214090Back 3 COLOR

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Fonte oficial

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