Active System; Avenue8
FDA 510(k) clearance K241395 · decided 2024-12-18
Clearance details
- K-number
- K241395
- Device name
- Active System; Avenue8
- Applicant
- Caerus Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-05-16
- Decision date
- 2024-12-18
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- ILX
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Blaine, MN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| Pulsed electromagnetic field wrap (K202337) | Hi-Dow International, Inc. | 2020-12-15 |
| RecoveryRx (K190251) | Bioelectronics Corporation | 2019-06-28 |
| PROVANT THERAPY SYSTEM (K131979) | Regenesis Biomedical, Inc. | 2013-12-13 |
| ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (K121702) | Orthocor Medical | 2013-05-06 |
| ZEOBI (K121338) | Ivivi Health Science, LLC | 2012-07-27 |
| PROVANT SYSTEM, MODEL 4201 (K091791) | Regenesis Biomedical, Inc. | 2010-04-07 |
| ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (K092044) | Orthocor Medical | 2009-12-18 |
| ORTHOCOR KNEE SYSTEM BASIC (K091996) | Orthocor Medical | 2009-12-15 |
| IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (K070541) | Ivivi Technologies, Inc. | 2008-12-11 |
| MODEL PMT850 (K070931) | Promedtek, Inc. | 2007-05-24 |
| ACTIBAND (K022404) | Paw, LLC | 2002-08-08 |
| REGENESIS MODEL 42 (K972093) | Regenesis Biomedical, Inc. | 1997-10-21 |
Recalls involving this device
No recalls on record reference this clearance.