Question 1

Who is the manufacturer of AESTHESIOMETER?

Accepted Answer

Orthopedic Systems, Inc. filed the 510(k) submission for AESTHESIOMETER (K874300).

Question 2

What is the FDA product code for AESTHESIOMETER?

Accepted Answer

GWI. It is classified under 21 CFR 882.1200 as a Class 1 device in the Neurology panel.

Question 3

When was AESTHESIOMETER cleared by the FDA?

Accepted Answer

Nov 6, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for AESTHESIOMETER?

Accepted Answer

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

Question 5

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

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	K874300
Device Name	AESTHESIOMETER
Applicant	Orthopedic Systems, Inc.
Product Code	GWI · Neurology
Decision Date	Nov 6, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1200
Device Class	Class 1

AESTHESIOMETER

Device Facts

Regulatory Classification

Identification