Home / 510(k) Clearances / K254267

510(k) K254267

NanoPress 760A-BT (760A-BT) by Mego Afek , Ltd. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2026
Date Received
December 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Mego Afek , Ltd.

  • K230385 — Ballancer Platinum (1222) (April 4, 2023)
  • 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 JOW

  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)
  • K232640 — Venowave VW5 (June 25, 2024)