Bio Boost
FDA 510(k) K961426 · Bio Compression Systems, Inc.
510(k) numberK961426
Submission
- Device name
- Bio Boost
- Applicant
- Bio Compression Systems, Inc.
Broadview Heights, OH, US - Received
- April 12, 1996
- Decision date
- October 28, 1996
- 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
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| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
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| 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 Bio Boost cleared by the FDA?
Bio Boost (K961426) received a 510(k) decision of Substantially Equivalent on October 28, 1996, 199 days after the submission was received.
What is the product code of K961426?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.