Total Contact Seat Ripple System
FDA 510(k) K943433 · Numotech, Inc.
510(k) numberK943433
Submission
- Device name
- Total Contact Seat Ripple System
- Applicant
- Numotech, Inc.
Sun Valley, CA, US - Received
- July 15, 1994
- Decision date
- July 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
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More from Hill-Rom, Inc.
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Questions and answers
When was Total Contact Seat Ripple System cleared by the FDA?
Total Contact Seat Ripple System (K943433) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 381 days after the submission was received.
What is the product code of K943433?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.