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FDA 510(k)

BIOTOUCH MASSAGE THERAPY SYSTEM

K-Number: K013061 · 2002-07-01

ApplicantTactile Systems Technology, Inc.
Decision Date2002-07-01
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOTOUCH MASSAGE THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Systems Technology, Inc.. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K013061. 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 BIOTOUCH MASSAGE THERAPY SYSTEM?

BIOTOUCH MASSAGE THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Tactile Systems Technology, Inc.. The 510(k) number is K013061.

When did BIOTOUCH MASSAGE THERAPY SYSTEM receive FDA 510(k) clearance?

BIOTOUCH MASSAGE THERAPY SYSTEM received FDA 510(k) clearance on 2002-07-01, under 510(k) number K013061.

Who is the listed applicant for BIOTOUCH MASSAGE THERAPY SYSTEM?

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

What is the FDA product code for BIOTOUCH MASSAGE THERAPY SYSTEM?

The FDA product code for BIOTOUCH MASSAGE THERAPY SYSTEM is IRP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tactile Systems Technology, Inc. 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.

K131193ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEMK120972FLEXITOUCH SYSTEMK062818FLEXITOUCH SYSTEM

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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