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FDA 510(k)

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

K-Number: K251623 · 2025-09-17

ApplicantShenzhen Yicai Health Technology Co., Ltd.
Decision Date2025-09-17
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251623. 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 Therapy Device (K1002/K1006/K1007/K1008/K1061)?

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. The 510(k) number is K251623.

When did Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) receive FDA 510(k) clearance?

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251623.

Who is the listed applicant for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?

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

What is the FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?

The FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is IRP.

Other records listing Shenzhen Yicai Health Technology Co., Ltd. as applicant

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.

K250784Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)K241119Transcutaneous Electrical Nerve Stimulator (K6106)

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.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare 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.

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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