Tenscare, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Tenscare, Ltd.” (first 2001, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 175 days. Since 2017 the median was 226 days, against 149 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 224 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 170 |
| 2020 | 0 | — |
| 2021 | 1 | 444 |
| 2022 | 0 | — |
| 2023 | 3 | 197 |
| 2024 | 1 | 382 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tenscare, Ltd. took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 4 | 4 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
Most recent Tenscare, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232441 | Unipro (K-UNIPRO-US) | GZJ | 2024-08-30 | 382 |
| K230926 | Ova+ (K-OVAP-USA) | NUH | 2023-12-15 | 256 |
| K230983 | Unicare (K-UNICARE-USA) | KPI | 2023-10-20 | 197 |
| K231053 | Unicare (K-UNICARE-USA) | NUH | 2023-08-18 | 127 |
| K200694 | Perfect EMS | NUH | 2021-06-04 | 444 |
| K191312 | Perfect PFE | KPI | 2019-11-01 | 170 |
| K142506 | TensCare KegelFit | KPI | 2015-04-20 | 224 |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | KPI | 2011-06-21 | 183 |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | GZJ | 2009-02-09 | 175 |
| K023997 | TENSCARE ULTIMA NMS/EMS | IPF | 2003-03-03 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tenscare, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tenscare, Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tenscare, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Tenscare, Ltd.” (first 2001, latest 2024), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tenscare, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tenscare, Ltd. is 175 days. Since 2017: 226 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tenscare, Ltd.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 5); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 4); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3).
Next steps
- See all 13 Tenscare, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Tenscare, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.