FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
TensCare KegelFit
K Number: K142506
·
Decision Apr 20, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
13
Review Days
224
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Basic Information
- Device Name
- TensCare KegelFit
- K Number
- K142506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tenscare, Ltd.
- Date Received
- September 8, 2014
- Decision Date
- April 20, 2015
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Tenscare, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K230983 | Unicare (K-UNICARE-USA) | Oct 20, 2023 | Substantially Equivalent |
| K231053 | Unicare (K-UNICARE-USA) | Aug 18, 2023 | Substantially Equivalent |
| K200694 | Perfect EMS | Jun 4, 2021 | Substantially Equivalent |
| K191312 | Perfect PFE | Nov 1, 2019 | Substantially Equivalent |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | Jun 21, 2011 | Substantially Equivalent |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | Feb 9, 2009 | Substantially Equivalent |
| K023997 | TENSCARE ULTIMA NMS/EMS | Mar 3, 2003 | Substantially Equivalent |
| K020846 | ULTIMA TENS XL-A1 | May 21, 2002 | Substantially Equivalent |