Classic NMS

FDA 510(k) K021905 · Care Rehab, Inc.

Substantially Equivalent

510(k) numberK021905

Submission

Device name
Classic NMS
Applicant
Care Rehab, Inc.
Mclean, VA, US
Received
June 10, 2002
Decision date
September 5, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Classic NMS cleared by the FDA?

Classic NMS (K021905) received a 510(k) decision of Substantially Equivalent on September 5, 2002, 87 days after the submission was received.

What is the product code of K021905?

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