Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control
FDA 510(k) K993413 · Invacare Corp.
Submission
- Device name
- Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- October 12, 1999
- Decision date
- December 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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Questions and answers
When was Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control cleared by the FDA?
Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control (K993413) received a 510(k) decision of Substantially Equivalent on December 15, 1999, 64 days after the submission was received.
What is the product code of K993413?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.