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510(k) K230385

Ballancer Platinum (1222) by Mego Afek — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2023
Date Received
February 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances by Mego Afek

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • K072372 — PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE (November 21, 2007)
  • K060220 — PBS MODEL 701A COMPRESSION THERAPY DEVICE (February 9, 2006)
  • K013331 — LYMPHA PRESS PLUS DEVICE (November 30, 2001)
  • K810338 — LYMPHA PRESS (October 20, 1981)

Other clearances for product code IRP

  • K251622 — Hand Massager (SM004D) (January 28, 2026)
  • K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) (November 13, 2025)
  • K251531 — AIR COMPRESSION BOOTS 1018195,1018196 (October 30, 2025)
  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K251905 — Normatec Elite Hip (September 18, 2025)
  • K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (September 17, 2025)
  • K250244 — Compression Therapy Device (LGT-2210DS) (July 25, 2025)
  • K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compress (July 23, 2025)
  • K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (May 5, 2025)
  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)