Jyrochair, Model Sk-H
FDA 510(k) K852015 · Medco Products, Co., Inc.
510(k) numberK852015
Submission
- Device name
- Jyrochair, Model Sk-H
- Applicant
- Medco Products, Co., Inc.
Tinton Falls, NJ, US - Received
- May 9, 1985
- Decision date
- July 19, 1985
- Decision
- Substantially Equivalent (SESE)
- 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 Jyrochair, Model Sk-H cleared by the FDA?
Jyrochair, Model Sk-H (K852015) received a 510(k) decision of Substantially Equivalent on July 19, 1985, 71 days after the submission was received.
What is the product code of K852015?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.