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FDA 510(k)

Air Compression Massager (EP30B001 I)

K-Number: K260948 · 2026-07-24

ApplicantWavepulse (Xiamen) Healthcare Technology Co., Ltd.
Decision Date2026-07-24
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Massager (EP30B001 I) is the device name listed in this FDA 510(k) record. The listed applicant is Wavepulse (Xiamen) Healthcare Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K260948. 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 Air Compression Massager (EP30B001 I)?

Air Compression Massager (EP30B001 I) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Wavepulse (Xiamen) Healthcare Technology Co., Ltd.. The 510(k) number is K260948.

When did Air Compression Massager (EP30B001 I) receive FDA 510(k) clearance?

Air Compression Massager (EP30B001 I) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K260948.

Who is the listed applicant for Air Compression Massager (EP30B001 I)?

The FDA 510(k) record lists Wavepulse (Xiamen) Healthcare Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Compression Massager (EP30B001 I)?

The FDA product code for Air Compression Massager (EP30B001 I) is IRP.

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.

K260944ManaCold Compression SystemManamed, LLCK260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE SaúdeK254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)Xiamen Weiyou Intelligent Technology 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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