Active System; Avenue8
FDA 510(k) K241395 · Caerus Corporation
510(k) numberK241395
Submission
- Device name
- Active System; Avenue8
- Applicant
- Caerus Corporation
Blaine, MN, US - Received
- May 16, 2024
- Decision date
- December 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
Other 510(k)s with product code ILX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202337 | Pulsed electromagnetic field wrapILX · Traditional | Hi-Dow International, Inc. | 12/15/2020SE |
| K190251 | RecoveryRxILX · Traditional | Bioelectronics Corporation | 06/28/2019SE |
| K131979 | Provant Therapy SystemILX · Traditional | Regenesis Biomedical, Inc. | 12/13/2013SE |
| K121702 | Orthocor Active Device Orthocor General Use Active DeviceILX · Traditional | Orthocor Medical | 05/06/2013SE |
| K121338 | ZeobiILX · Special | Ivivi Health Science, LLC | 07/27/2012SE |
| K091791 | Provant System, Model 4201ILX · Traditional | Regenesis Biomedical, Inc. | 04/07/2010SE |
| K092044 | Orthocor Knee System, Median, Large, X-LargeILX · Traditional | Orthocor Medical | 12/18/2009SE |
| K091996 | Orthocor Knee System BasicILX · Traditional | Orthocor Medical | 12/15/2009SE |
| K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIILX · Traditional | Ivivi Technologies, Inc. | 12/11/2008SE |
| K070931 | Model PMT850ILX · Traditional | Promedtek, Inc. | 05/24/2007SE |
Questions and answers
When was Active System; Avenue8 cleared by the FDA?
Active System; Avenue8 (K241395) received a 510(k) decision of Substantially Equivalent on December 18, 2024, 216 days after the submission was received.
What is the product code of K241395?
The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.