Question 1

Who is the manufacturer of LOWER EXTREMITY SUPPORT SYSTEM-LESS?

Accepted Answer

Walgen Medical Innoventions filed the 510(k) submission for LOWER EXTREMITY SUPPORT SYSTEM-LESS (K810433).

Question 2

What is the FDA product code for LOWER EXTREMITY SUPPORT SYSTEM-LESS?

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 LOWER EXTREMITY SUPPORT SYSTEM-LESS cleared by the FDA?

Accepted Answer

Mar 13, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for LOWER EXTREMITY SUPPORT SYSTEM-LESS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LOWER EXTREMITY SUPPORT SYSTEM-LESS?

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	K810433
Device Name	LOWER EXTREMITY SUPPORT SYSTEM-LESS
Applicant	Walgen Medical Innoventions
Product Code	FWZ · General, Plastic Surgery
Decision Date	Mar 13, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

LOWER EXTREMITY SUPPORT SYSTEM-LESS

Device Facts

Regulatory Classification

Identification