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510(k) K241395

Active System; Avenue8 by Caerus Corporation — Product Code ILX

K241395 is an FDA 510(k) premarket notification submitted by Caerus Corporation for the device "Active System; Avenue8". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
May 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances for product code ILX

  • K202337 — Pulsed electromagnetic field wrap (December 15, 2020)
  • K190251 — RecoveryRx (June 28, 2019)
  • K131979 — PROVANT THERAPY SYSTEM (December 13, 2013)
  • K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (May 6, 2013)
  • K121338 — ZEOBI (July 27, 2012)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)
  • K092044 — ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (December 18, 2009)
  • K091996 — ORTHOCOR KNEE SYSTEM BASIC (December 15, 2009)
  • K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (December 11, 2008)
  • K070931 — MODEL PMT850 (May 24, 2007)

FDA data resources