Question 1

Who is the manufacturer of MENS FREEDOM MICRO?

Accepted Answer

Monad Corp. filed the 510(k) submission for MENS FREEDOM MICRO (K904430).

Question 2

What is the FDA product code for MENS FREEDOM MICRO?

Accepted Answer

GZJ. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

Question 3

When was MENS FREEDOM MICRO cleared by the FDA?

Accepted Answer

May 13, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for MENS FREEDOM MICRO?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like MENS FREEDOM MICRO?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K904430
Device Name	MENS FREEDOM MICRO
Applicant	Monad Corp.
Product Code	GZJ · Neurology
Decision Date	May 13, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2

MENS FREEDOM MICRO

Device Facts

Regulatory Classification

Identification