Mobile Standing Frame
FDA 510(k) K924314 · Metatech Corp.
510(k) numberK924314
Submission
- Device name
- Mobile Standing Frame
- Applicant
- Metatech Corp.
Westminster, MD, US - Received
- August 26, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IPL – Wheelchair, Standup
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3900
- Specialty
- Physical Medicine
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Questions and answers
When was Mobile Standing Frame cleared by the FDA?
Mobile Standing Frame (K924314) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 170 days after the submission was received.
What is the product code of K924314?
The FDA product code is IPL – Wheelchair, Standup, a Class II (moderate risk) device regulated under 21 CFR 890.3900.