K-number	K254267
Device name	NanoPress 760A-BT (760A-BT)
Applicant	Mego Afek , Ltd.
Product code	JOW
Device class	Class II
Decision date	Feb 24, 2026
Decision	Substantially Equivalent
Regulation	870.5800

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The NanoPress 760A-BT is a pneumatic compression therapy system indicated for treating primary and secondary lymphedema, venous insufficiency, venous stasis ulcers, and dysfunction of the muscle pump. It is a prescription-use medical device classified as a Class II compressible limb sleeve.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to the Quality Management System Regulation (QMSR) including ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action), though specific test standards or consensus standards are not detailed in this clearance letter.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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NanoPress 760A-BT (760A-BT)

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