Question 1

Who is the manufacturer of 4000+?

Accepted Answer

U.S. Therapy Products, Inc. filed the 510(k) submission for 4000+ (K950783).

Question 2

What is the FDA product code for 4000+?

Accepted Answer

IPF. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

Question 3

When was 4000+ cleared by the FDA?

Accepted Answer

Oct 27, 1995 (decision: SN).

Question 4

What is the regulatory pathway for 4000+?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like 4000+?

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	K950783
Device Name	4000+
Applicant	U.S. Therapy Products, Inc.
Product Code	IPF · Physical Medicine
Decision Date	Oct 27, 1995
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2

4000+

Device Facts

Regulatory Classification

Identification