Portable Therapeutix Squid Active Cold Compression Device and Cold Pack
FDA 510(k) K123829 · Portable Therapeutix, LLC
510(k) numberK123829
Submission
- Device name
- Portable Therapeutix Squid Active Cold Compression Device and Cold Pack
- Applicant
- Portable Therapeutix, LLC
Ashland, MA, US - Received
- December 12, 2012
- Decision date
- April 3, 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
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| 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 |
|---|---|---|
| K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for OTC UseIRP · Traditional | 03/11/2014SE |
Questions and answers
When was Portable Therapeutix Squid Active Cold Compression Device and Cold Pack cleared by the FDA?
Portable Therapeutix Squid Active Cold Compression Device and Cold Pack (K123829) received a 510(k) decision of Substantially Equivalent on April 3, 2013, 112 days after the submission was received.
What is the product code of K123829?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.