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FDA 510(k)

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM

K-Number: K122112 · 2013-04-09

ApplicantBio Compression Systems, Inc.
Decision Date2013-04-09
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K122112. 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 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM?

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K122112.

When did 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM receive FDA 510(k) clearance?

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM received FDA 510(k) clearance on 2013-04-09, under 510(k) number K122112.

Who is the listed applicant for 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM?

The FDA 510(k) record lists Bio Compression Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM?

The FDA product code for 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM 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.

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

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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