Automove, Model AM800

FDA 510(k) K032955 · Danmeter A/S

Substantially Equivalent

510(k) numberK032955

Submission

Device name
Automove, Model AM800
Applicant
Danmeter A/S
Odense C, DK
Received
September 22, 2003
Decision date
December 15, 2003
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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Questions and answers

When was Automove, Model AM800 cleared by the FDA?

Automove, Model AM800 (K032955) received a 510(k) decision of Substantially Equivalent on December 15, 2003, 84 days after the submission was received.

What is the product code of K032955?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.