FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
TENSCARE, MODEL TENS XL-2
K Number: K003591
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
13
Review Days
85
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Basic Information
- Device Name
- TENSCARE, MODEL TENS XL-2
- K Number
- K003591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tenscare, Ltd.
- Date Received
- November 21, 2000
- Decision Date
- February 14, 2001
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Tenscare, Ltd.
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|---|---|---|---|
| K232441 | Unipro (K-UNIPRO-US) | Aug 30, 2024 | Substantially Equivalent |
| K230926 | Ova+ (K-OVAP-USA) | Dec 15, 2023 | Substantially Equivalent |
| 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 |
| K142506 | TensCare KegelFit | Apr 20, 2015 | 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 |