Mens Freedom Micro

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904430 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• My-O-Matic 5000I

  Class II

  FDA 510(k) K902226 Active Cleared 6 Jun 1991

• Mens-O-Matic 3000

  Class II

  FDA 510(k) K904260 Active Cleared 13 May 1991

• Mens-O-Matic 2000

  Class II

  FDA 510(k) K904235 Active Cleared 13 May 1991

• Phaser (Single Linear Mechanical Massage)

  Class I

  FDA 510(k) K891871 Active Cleared 25 Apr 1989

• Mens 2000-D

  Class II

  FDA 510(k) K914441 Active Cleared 17 Dec 1991

• Mens-O-Matic 1XS and Mens-O-Matic 2XS

  Class II

  FDA 510(k) K904288 Active Cleared 13 May 1991

See all devices from Monad Corp. →

• What is the primary purpose of the Mens Freedom Micro device, and who is it designed for?

  The Mens Freedom Micro is a male external urinary collection device designed to provide a non-invasive way to collect urine for individuals experiencing urinary incontinence or other conditions requiring external drainage. It is intended for single-use applications and is engineered to offer comfort and ease of use, particularly for patients needing continuous urinary collection outside of a clinical setting.

• Is the Mens Freedom Micro device reusable or intended for single-use, and how is it supplied?

  The Mens Freedom Micro is explicitly designed for single-use only, as confirmed by its FDA 510(k) clearance (K904430). It is supplied sterile to ensure safety and hygiene for each use, requiring no reprocessing or reuse.

• How should the Mens Freedom Micro device be stored to maintain its sterility before use?

  Since the device is sterile upon packaging, it must be stored under appropriate conditions to preserve sterility until use. This typically means keeping it in its sealed, unopened packaging away from moisture, extreme temperatures, and contamination until ready for application.

• What regulatory pathway was followed for FDA clearance of the Mens Freedom Micro, and what classification does it hold?

  The Mens Freedom Micro received FDA 510(k) clearance (K904430) under the Neurology advisory committee via a traditional review process, with a decision of *Substantially Equivalent* (SESE). It is classified as a Class II medical device, which requires compliance with specific regulatory controls but does not imply clinical restrictions beyond its intended use.