NanoPress 760A-BT (760A-BT)— 510(k) K254267
Substantially EquivalentMego Afek , Ltd.
FDA 510(k) clearance K254267 for NanoPress 760A-BT (760A-BT), Substantially Equivalent on 2026-02-24. Applicant: Mego Afek , Ltd.. Device class: 2.
Summary
Mego Afek's NanoPress 760A-BT (760A-BT) is filed under product code JOW, compressible limb sleeve. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 870.5800. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Mego Afek filed from Kibbuts Afek, Israel. FDA found it substantially equivalent 56 calendar days after receipt (December 30, 2025 to February 24, 2026).
Clearance details
- Applicant
- Mego Afek , Ltd.
- Product code
- Product code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kibbuts Afek, IL
Recent devices under product code JOW
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