Nanma Vacuum Pump

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

510(k) Number

K030913 ↗

FDA Product Code

LKY

Device Class

Class II

Regulation

21 CFR Part 876.5020

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Nanma Ajustable Constriction Ring

  Class II

  FDA 510(k) K993908 Active Cleared 31 Jan 2000

• Modification to Nanma Vacuum Pump

  Class II

  FDA 510(k) K013113 Active Cleared 20 Dec 2002

• Nanma Vacuum Pump

  Class II

  FDA 510(k) K993909 Active Cleared 19 Jul 2000

• Nanma Adjustable Constriction Ring

  Class II

  FDA 510(k) K030119 Active Cleared 6 Aug 2003

• Nanma Non-Adjustable Constriction Ring

  Class II

  FDA 510(k) K993906 Active Cleared 31 Jan 2000

• Nanma Vacuum Pump Proxzek Model 2M9498S

  Class II

  FDA 510(k) K041573 Active Cleared 25 Aug 2004

See all devices from Nanma Mfg Co., Ltd. →

• What is the Nanma Vacuum Pump Model 2M9498S used for?

  The Nanma Vacuum Pump Model 2M9498S is an external penile rigidity device designed to generate erections in men experiencing erectile dysfunction. It works by creating a vacuum around the penis, which increases blood flow and promotes sufficient rigidity for sexual intercourse. This device is specifically categorized under external penile rigidity aids and is intended for urological applications.

• Is the Nanma Vacuum Pump Model 2M9498S reusable or single-use?

  The Nanma Vacuum Pump Model 2M9498S is classified as a reusable medical device. This means it is intended for repeated use in clinical settings, such as urology or gastroenterology, after proper cleaning and maintenance. Reusability is a key feature for cost-effective and practical use in healthcare environments.

• What regulatory classification and clearance does the Nanma Vacuum Pump Model 2M9498S hold?

  The Nanma Vacuum Pump Model 2M9498S is categorized as a Class II medical device under FDA regulation number 876.5020. It holds an FDA 510(k) clearance (K030913) and is deemed substantially equivalent to a predicate device. This classification reflects its role as a reusable external penile rigidity aid, ensuring it meets stringent safety and performance standards for clinical use.

• What are the primary clinical applications for this device?

  While the primary function of the Nanma Vacuum Pump Model 2M9498S is to assist men with erectile dysfunction by inducing penile rigidity, it is also listed under FDA advisory committees for gastroenterology and urology. This indicates its potential use in clinical settings where penile rigidity assessment or support may be relevant, though its core indication remains external penile rigidity for sexual function.

• How should the Nanma Vacuum Pump Model 2M9498S be stored?

  The device data does not specify storage instructions, but as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination or damage. Proper maintenance, including cleaning between uses, is essential to ensure hygiene and longevity. Always follow manufacturer guidelines for cleaning and storage if additional details are provided elsewhere.