Tenscare Ltd.
EPSOM Surrey, GB
TENSCARE LTD. appears in FDA device records in EPSOM Surrey, GB. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Tenscare Ltd. between 2001 and 2024. The busiest year on record is 2023, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232441 | Unipro (K-UNIPRO-US) | GZJ | Substantially Equivalent | |
| K230926 | Ova+ (K-OVAP-USA) | NUH | Substantially Equivalent | |
| K230983 | Unicare (K-UNICARE-USA) | KPI | Substantially Equivalent | |
| K231053 | Unicare (K-UNICARE-USA) | NUH | Substantially Equivalent | |
| K200694 | Perfect EMS | NUH | Substantially Equivalent | |
| K191312 | Perfect PFE | KPI | Substantially Equivalent | |
| K142506 | TensCare KegelFit | KPI | Substantially Equivalent | |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | KPI | Substantially Equivalent | |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | GZJ | Substantially Equivalent | |
| K023997 | TENSCARE ULTIMA NMS/EMS | IPF | Substantially Equivalent | |
| K020846 | ULTIMA TENS XL-A1 | GZJ | Substantially Equivalent | |
| K011543 | TENS CARE, MODEL XL-Y3 | GZJ | Substantially Equivalent | |
| K003591 | TENSCARE, MODEL TENS XL-2 | GZJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003446042 | 3003446042 | TENSCARE LTD. | PAINAWAY HOUSE, 9 BLENHEIM ROAD, EPSOM Surrey KT19 9BE GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GXYElectrode, Cutaneous
- NUCLubricant, Personal
- ISAMassager, Therapeutic, Electric
- HGXPump, Breast, Powered
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain