Biotouch Massage Therapy System

FDA 510(k) K013061 · Tactile Systems Technology, Inc.

Substantially Equivalent

510(k) numberK013061

Submission

Device name
Biotouch Massage Therapy System
Applicant
Tactile Systems Technology, Inc.
Shakopee, MN, US
Received
September 11, 2001
Decision date
July 1, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IRP – Massager, Powered Inflatable Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5650
Specialty
Physical Medicine

Other 510(k)s with product code IRP

510(k)DeviceApplicantDecision
K260944ManaCold Compression SystemIRP · Traditional Manamed, LLC08/12/2026SE
K260529Air Compression Massager (HY-1165)IRP · Traditional Xiamen High Top Electronic Technology Co., Ltd.07/27/2026SE
K260948Air Compression Massager (EP30B001 I)IRP · Traditional Wavepulse (Xiamen) Healthcare Technology Co., Ltd.07/24/2026SE
K253919Cryo And Thermo Therapy SystemIRP · Traditional Xiamen Weiyou Intelligent Technology Co., Ltd.06/10/2026SE
K252396Cryo Sport 2.0 (AVA 501)IRP · Traditional Avanutri Equipamentos DE Saúde05/29/2026SE
K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…IRP · Traditional Wenzhou Lingfeng Electronic Technology Co., Ltd.05/05/2026SE
K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional Xiamen Weiyou Intelligent Technology Co., Ltd.04/30/2026SE
K252386Hot and Cold Compression System (A02-C-032)IRP · Traditional Chengdu Cryo-Push Medical Technology Co.,Ltd04/03/2026SE
K253076Cryopush Cold Compression Device (A02-P-001)IRP · Traditional Chengdu Cryo-Push Medical Technology Co.,Ltd04/02/2026SE
K251622Hand Massager (SM004D)IRP · Traditional Ningbo Zhenhai Yihao Electronic Technology Co.…01/28/2026SE

More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.

510(k)DeviceDecision
K143185entré Model PD08-UJOW · Traditional 05/07/2015SE
K131193Actitouch Act-Adaptive Compression Therapy SystemJOW · Traditional 06/18/2013SE
K120972Flexitouch SystemJOW · Traditional 04/13/2012SE
K062818Flexitouch SystemJOW · Traditional 10/06/2006SE

Questions and answers

When was Biotouch Massage Therapy System cleared by the FDA?

Biotouch Massage Therapy System (K013061) received a 510(k) decision of Substantially Equivalent on July 1, 2002, 293 days after the submission was received.

What is the product code of K013061?

The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.