If-Ii (TM), Model 7200
FDA 510(k) K923914 · Medical Devices, Inc.
510(k) numberK923914
Submission
- Device name
- If-Ii (TM), Model 7200
- Applicant
- Medical Devices, Inc.
St. Paul, MN, US - Received
- July 31, 1992
- Decision date
- November 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 If-Ii (TM), Model 7200 cleared by the FDA?
If-Ii (TM), Model 7200 (K923914) received a 510(k) decision of Substantially Equivalent on November 6, 1992, 98 days after the submission was received.
What is the product code of K923914?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.