Who is the manufacturer of JAZZY?

Pride Health Care, Inc. submitted the Traditional clearance for JAZZY (K945936).

What is the FDA product code for JAZZY?

ITI. It is classified under 21 CFR 890.3860 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for JAZZY?

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

JAZZY

K945936 · Pride Health Care, Inc. · ITI · May 28, 1996 · Physical Medicine

Device Facts

Record ID	K945936
Device Name	JAZZY
Applicant	Pride Health Care, Inc.
Product Code	ITI · Physical Medicine
Decision Date	May 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3860
Device Class	Class 2

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.