Question 1

Who is the manufacturer of THE PORTABLE ORDERLY?

Accepted Answer

Edgewater Medical Equipment Systems filed the 510(k) submission for THE PORTABLE ORDERLY (K872900).

Question 2

What is the FDA product code for THE PORTABLE ORDERLY?

Accepted Answer

FWZ. It is classified under 21 CFR 878.4950 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was THE PORTABLE ORDERLY cleared by the FDA?

Accepted Answer

Aug 21, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for THE PORTABLE ORDERLY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like THE PORTABLE ORDERLY?

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	K872900
Device Name	THE PORTABLE ORDERLY
Applicant	Edgewater Medical Equipment Systems
Product Code	FWZ · General, Plastic Surgery
Decision Date	Aug 21, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

THE PORTABLE ORDERLY

Device Facts

Regulatory Classification

Identification