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FDA 510(k)

Phyziofit Medical Surgical Mask

K-Number: K201868 · 2021-02-22

ApplicantWellpower Sporting Goods Co., Ltd.
Decision Date2021-02-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phyziofit Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wellpower Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K201868. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phyziofit Medical Surgical Mask?

Phyziofit Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Wellpower Sporting Goods Co., Ltd.. The 510(k) number is K201868.

When did Phyziofit Medical Surgical Mask receive FDA 510(k) clearance?

Phyziofit Medical Surgical Mask received FDA 510(k) clearance on 2021-02-22, under 510(k) number K201868.

Who is the listed applicant for Phyziofit Medical Surgical Mask?

The FDA 510(k) record lists Wellpower Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phyziofit Medical Surgical Mask?

The FDA product code for Phyziofit Medical Surgical Mask is FXX.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.

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