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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 a medical device manufactured by Wellpower Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-02-22 under approval 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. It is manufactured by Wellpower Sporting Goods Co., Ltd.. The 510(k) number is K201868.

When was Phyziofit Medical Surgical Mask approved by the FDA?

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

What company makes Phyziofit Medical Surgical Mask?

Phyziofit Medical Surgical Mask is manufactured by Wellpower Sporting Goods Co., Ltd..

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

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

Related Clinical Trials

NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING

Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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