Rumors Dynamic Air Therapy Unit
FDA 510(k) K972111 · Hill-Rom, Inc.
510(k) numberK972111
Submission
- Device name
- Rumors Dynamic Air Therapy Unit
- Applicant
- Hill-Rom, Inc.
Charleston, SC, US - Received
- June 5, 1997
- Decision date
- February 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKZ – Bed, Patient Rotation, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5225
- Specialty
- Physical Medicine
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| K933964 | The CradleIKZ · Traditional | The Primal Energy Research Foundation | 10/03/1994SE |
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Questions and answers
When was Rumors Dynamic Air Therapy Unit cleared by the FDA?
Rumors Dynamic Air Therapy Unit (K972111) received a 510(k) decision of Substantially Equivalent on February 2, 1998, 242 days after the submission was received.
What is the product code of K972111?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.