Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tenscare, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
382 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024-08-30 | 382 | 0 |
| K230926 | Ova+ (K-OVAP-USA) | Tenscare, Ltd. | 2023-12-15 | 256 | 0 |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-10-20 | 197 | 0 |
| K231053 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-08-18 | 127 | 0 |
| K200694 | Perfect EMS | Tenscare, Ltd. | 2021-06-04 | 444 | 0 |
| K191312 | Perfect PFE | Tenscare, Ltd. | 2019-11-01 | 170 | 0 |
| K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015-04-20 | 224 | 0 |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | Tenscare, Ltd. | 2011-06-21 | 183 | 0 |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | Tenscare, Ltd. | 2009-02-09 | 175 | 0 |
| K023997 | TENSCARE ULTIMA NMS/EMS | Tenscare, Ltd. | 2003-03-03 | 90 | 0 |
| K020846 | ULTIMA TENS XL-A1 | Tenscare, Ltd. | 2002-05-21 | 67 | 0 |
| K011543 | TENS CARE, MODEL XL-Y3 | Tenscare, Ltd. | 2001-08-31 | 105 | 0 |
| K003591 | TENSCARE, MODEL TENS XL-2 | Tenscare, Ltd. | 2001-02-14 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda