KINESIA

Transducer, Tremor

CLEVELAND MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Kinesia.

Pre-market Notification Details

• Device ID: K063872
• 510k Number: K063872
• Device Name: KINESIA
• Classification: Transducer, Tremor
• Applicant: CLEVELAND MEDICAL DEVICES, INC. 4415 EUCLID AVE Cleveland, OH 44103
• Contact: Joseph Giuffrida
• Correspondent: Joseph Giuffrida; CLEVELAND MEDICAL DEVICES, INC. 4415 EUCLID AVE Cleveland, OH 44103
• Product Code: GYD
• CFR Regulation Number: 882.1950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-12-29
• Decision Date: 2007-04-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859584006270	K063872	000
00859584006089	K063872	000
00859584006072	K063872	000
00859584006065	K063872	000
00859584006058	K063872	000
00859584006041	K063872	000
00859584006034	K063872	000
00859584006027	K063872	000
00859584006010	K063872	000
00859584006003	K063872	000
00859584006096	K063872	000
00859584006102	K063872	000
00859584006140	K063872	000
00859584006119	K063872	000
00859584006126	K063872	000
00859584006263	K063872	000
00859584006256	K063872	000
00859584006249	K063872	000
00859584006232	K063872	000
00859584006225	K063872	000
00859584006218	K063872	000
00859584006201	K063872	000
00859584006195	K063872	000
00859584006188	K063872	000
00859584006171	K063872	000
00859584006164	K063872	000
00859584006133	K063872	000
00859584006157	K063872	000