Vollman Prone Positioner
FDA 510(k) K963091 · Hill-Rom, Inc.
510(k) numberK963091
Submission
- Device name
- Vollman Prone Positioner
- Applicant
- Hill-Rom, Inc.
Charleston, SC, US - Received
- August 8, 1996
- Decision date
- January 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPT – Orthosis, Thoracic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
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| K761128 | Lateral Trunk SupportsIPT · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
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Questions and answers
When was Vollman Prone Positioner cleared by the FDA?
Vollman Prone Positioner (K963091) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 154 days after the submission was received.
What is the product code of K963091?
The FDA product code is IPT – Orthosis, Thoracic, a Class I (low risk) device regulated under 21 CFR 890.3490.