Tenscare Ultima Nms/Ems
FDA 510(k) K023997 · Tenscare, Ltd.
510(k) numberK023997
Submission
- Device name
- Tenscare Ultima Nms/Ems
- Applicant
- Tenscare, Ltd.
Timperley, Cheshire, GB - Received
- December 3, 2002
- Decision date
- March 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K200694 | Perfect EMSNUH · Traditional | 06/04/2021SE |
| K191312 | Perfect PFEKPI · Traditional | 11/01/2019SE |
| K142506 | TensCare KegelFitKPI · Traditional | 04/20/2015SE |
| K103698 | Tenscare Itouch Sure Model ItsKPI · Traditional | 06/21/2011SE |
| K082377 | Tenscare Itouch Model(S) Easy and PlusGZJ · Abbreviated | 02/09/2009SE |
| K020846 | Ultima TENS XL-A1GZJ · Traditional | 05/21/2002SE |
Questions and answers
When was Tenscare Ultima Nms/Ems cleared by the FDA?
Tenscare Ultima Nms/Ems (K023997) received a 510(k) decision of Substantially Equivalent on March 3, 2003, 90 days after the submission was received.
What is the product code of K023997?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.