2004-OC Massage System, 2008-OC Massage System
FDA 510(k) K122112 · Bio Compression Systems, Inc.
510(k) numberK122112
Submission
- Device name
- 2004-OC Massage System, 2008-OC Massage System
- Applicant
- Bio Compression Systems, Inc.
Toms River, NJ, US - Received
- July 17, 2012
- Decision date
- April 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K260944 | ManaCold Compression SystemIRP · Traditional | Manamed, LLC | 08/12/2026SE |
| K260529 | Air Compression Massager (HY-1165)IRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 07/27/2026SE |
| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
| K253919 | Cryo And Thermo Therapy SystemIRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/10/2026SE |
| K252396 | Cryo Sport 2.0 (AVA 501)IRP · Traditional | Avanutri Equipamentos DE Saúde | 05/29/2026SE |
| K254200 | Air 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 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 04/30/2026SE |
| K252386 | Hot and Cold Compression System (A02-C-032)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/03/2026SE |
| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
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| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…IRP · Traditional | 02/16/2022SE |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…JOW · Traditional | 05/14/2021SE |
| K180248 | VascuEase IC-1200-WHJOW · Traditional | 08/07/2018SE |
| K171793 | Sequential Circulator SC-2004FC-OCJOW · Special | 08/17/2017SE |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OCJOW · Special | 07/16/2015SE |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model…JOW · Traditional | 11/06/2014SE |
| K131306 | IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression DeviceJOW · Traditional | 07/22/2013SE |
| K131327 | Bioarterial Plus Arterial Blood Flow Enhancement SystemJOW · Traditional | 07/18/2013SE |
Questions and answers
When was 2004-OC Massage System, 2008-OC Massage System cleared by the FDA?
2004-OC Massage System, 2008-OC Massage System (K122112) received a 510(k) decision of Substantially Equivalent on April 9, 2013, 266 days after the submission was received.
What is the product code of K122112?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.