510(k) K032955

AUTOMOVE, MODEL AM800 by Danmeter A/S — Product Code IPF

K032955 is an FDA 510(k) premarket notification submitted by Danmeter A/S for the device "AUTOMOVE, MODEL AM800". The FDA issued a decision of Substantially Equivalent on December 15, 2003. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Danmeter A/S has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2003
Date Received
September 22, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type