Model 1100 Cold Therapy Device
FDA 510(k) K970533 · Smith & Nephew, Inc.
510(k) numberK970533
Submission
- Device name
- Model 1100 Cold Therapy Device
- Applicant
- Smith & Nephew, Inc.
Carlsbad, CA, US - Received
- February 12, 1997
- Decision date
- April 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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Questions and answers
When was Model 1100 Cold Therapy Device cleared by the FDA?
Model 1100 Cold Therapy Device (K970533) received a 510(k) decision of Substantially Equivalent on April 15, 1997, 62 days after the submission was received.
What is the product code of K970533?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.