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FDA 510(k)

Cryo Sport 2.0 (AVA 501)

K-Number: K252396 · 2026-05-29

ApplicantAvanutri Equipamentos DE Saúde
Decision Date2026-05-29
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Cryo Sport 2.0 (AVA 501) is the device name listed in this FDA 510(k) record. The listed applicant is Avanutri Equipamentos DE Saúde. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252396. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cryo Sport 2.0 (AVA 501)?

Cryo Sport 2.0 (AVA 501) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Avanutri Equipamentos DE Saúde. The 510(k) number is K252396.

When did Cryo Sport 2.0 (AVA 501) receive FDA 510(k) clearance?

Cryo Sport 2.0 (AVA 501) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252396.

Who is the listed applicant for Cryo Sport 2.0 (AVA 501)?

The FDA 510(k) record lists Avanutri Equipamentos DE Saúde as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryo Sport 2.0 (AVA 501)?

The FDA product code for Cryo Sport 2.0 (AVA 501) is IRP.

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Related Devices (Code: IRP)

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.

K261887Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)NormaTec Industries, LPK262812Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)Sichuan Qianli-Beoka Medical Technology, Inc.K260944ManaCold Compression SystemManamed, LLCK260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.

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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