Multipulse Sequential Compression Unit
FDA 510(k) K914774 · Talley Group, Ltd.
510(k) numberK914774
Submission
- Device name
- Multipulse Sequential Compression Unit
- Applicant
- Talley Group, Ltd.
Lansing, MI, US - Received
- October 23, 1991
- Decision date
- February 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| K914780 | Talley SD.500 Skin Pressure EvaluatorIKE · Traditional | 12/19/1991SE |
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Questions and answers
When was Multipulse Sequential Compression Unit cleared by the FDA?
Multipulse Sequential Compression Unit (K914774) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 111 days after the submission was received.
What is the product code of K914774?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.