Easystand Evolv
FDA 510(k) K062402 · Invacare Corp.
510(k) numberK062402
Submission
- Device name
- Easystand Evolv
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- August 17, 2006
- Decision date
- September 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INO – Chair, Positioning, Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3110
- Specialty
- Physical Medicine
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Questions and answers
When was Easystand Evolv cleared by the FDA?
Easystand Evolv (K062402) received a 510(k) decision of Substantially Equivalent on September 21, 2006, 35 days after the submission was received.
What is the product code of K062402?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.