Action Tiger Powered Wheelchair
FDA 510(k) K930676 · Invacare Corp.
510(k) numberK930676
Submission
- Device name
- Action Tiger Powered Wheelchair
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- February 9, 1993
- Decision date
- March 25, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 Action Tiger Powered Wheelchair cleared by the FDA?
Action Tiger Powered Wheelchair (K930676) received a 510(k) decision of Substantially Equivalent for Some Indications on March 25, 1994, 409 days after the submission was received.
What is the product code of K930676?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.