Infinity Plus Electrotherapy System
FDA 510(k) K041920 · Empi
510(k) numberK041920
Submission
- Device name
- Infinity Plus Electrotherapy System
- Applicant
- Empi
North Attleboro, MA, US - Received
- July 16, 2004
- Decision date
- January 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Infinity Plus Electrotherapy System cleared by the FDA?
Infinity Plus Electrotherapy System (K041920) received a 510(k) decision of Substantially Equivalent on January 21, 2005, 189 days after the submission was received.
What is the product code of K041920?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.