Question 1

Who is the manufacturer of MED-TEC HAND GRIP?

Accepted Answer

Medtec, Inc. filed the 510(k) submission for MED-TEC HAND GRIP (K954225).

Question 2

What is the FDA product code for MED-TEC HAND GRIP?

Accepted Answer

IXQ. It is classified under 21 CFR 892.1980 as a Class 2 device in the Radiology panel.

Question 3

When was MED-TEC HAND GRIP cleared by the FDA?

Accepted Answer

Nov 14, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for MED-TEC HAND GRIP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MED-TEC HAND GRIP?

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	K954225
Device Name	MED-TEC HAND GRIP
Applicant	Medtec, Inc.
Product Code	IXQ · Radiology
Decision Date	Nov 14, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1980
Device Class	Class 2

MED-TEC HAND GRIP

Device Facts

Regulatory Classification

Identification

Special Controls