Medical Device Manufacturer · GB , Timperley, Cheshire

Tenscare, Ltd.

13 submissions · 13 cleared · Since 2001
13
Total
13
Cleared
0
Denied

Tenscare, Ltd. — FDA 510(k) Submissions

Tenscare, Ltd. has submitted 13 FDA 510(k) premarket notifications since 2001, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Transcutaneous, For Pain Relief, Stimulator, Electrical, Non-implantable, For Incontinence, Stimulator, Nerve, Transcutaneous, Over-the-counter, Stimulator, Muscle, Powered . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
Unipro (K-UNIPRO-US)
K232441 · GZJ Stimulator, Nerve,... · Neurology
Aug 2024 382d
Ova+ (K-OVAP-USA)
K230926 · NUH Stimulator, Nerve,... · Neurology
Dec 2023 256d
Unicare (K-UNICARE-USA)
K230983 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Oct 2023 197d
Unicare (K-UNICARE-USA)
K231053 · NUH Stimulator, Nerve,... · Neurology
Aug 2023 127d
Perfect EMS
K200694 · NUH Stimulator, Nerve,... · Neurology
Jun 2021 444d
Perfect PFE
K191312 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Nov 2019 170d
TensCare KegelFit
K142506 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Apr 2015 224d
TENSCARE ITOUCH SURE MODEL ITS
K103698 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Jun 2011 183d
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
K082377 · GZJ Stimulator, Nerve,... · Neurology
Feb 2009 175d
TENSCARE ULTIMA NMS/EMS
K023997 · IPF Stimulator, Muscle, Powered · Physical Medicine
Mar 2003 90d
ULTIMA TENS XL-A1
K020846 · GZJ Stimulator, Nerve,... · Neurology
May 2002 67d
TENS CARE, MODEL XL-Y3
K011543 · GZJ Stimulator, Nerve,... · Neurology
Aug 2001 105d
TENSCARE, MODEL TENS XL-2
K003591 · GZJ Stimulator, Nerve,... · Neurology
Feb 2001 85d
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