Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Well-Life Healthcare Limited · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
283 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator | Well-Life Healthcare Limited | 2024-10-18 | 389 | 0 |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: | Well-Life Healthcare Limited | 2022-12-29 | 129 | 0 |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | Well-Life Healthcare Limited | 2022-08-04 | 162 | 0 |
| K213091 | Well-Life TENS/EMS/Heating Stimulator | Well-Life Healthcare Limited | 2022-02-19 | 148 | 0 |
| K200942 | Well-Life Garment Electrodes (GM Series) | Well-Life Healthcare Limited | 2021-06-01 | 419 | 0 |
| K172809 | OTC Combo TENS/EMS System | Well-Life Healthcare Limited | 2017-10-18 | 30 | 0 |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/260 | Well-Life Healthcare Limited | 2017-01-17 | 113 | 0 |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | Well-Life Healthcare Limited | 2016-12-05 | 193 | 0 |
| K141299 | OTC COMBO TENS/EMS SYSTEM | Well-Life Healthcare Limited | 2014-11-14 | 179 | 0 |
| K133723 | OTC PATCH | Well-Life Healthcare Limited | 2014-01-28 | 53 | 0 |
| K123075 | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STI | Well-Life Healthcare Limited | 2013-07-11 | 283 | 0 |
| K121353 | MINI PATCH | Well-Life Healthcare Limited | 2012-09-07 | 126 | 0 |
| K102786 | WELL-LIFE OTC EMS SYSTEM | Well-Life Healthcare Limited | 2011-07-01 | 277 | 0 |
| K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MOD | Well-Life Healthcare Limited | 2010-06-25 | 129 | 0 |
| K091757 | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 | Well-Life Healthcare Limited | 2010-02-05 | 234 | 0 |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | Well-Life Healthcare Limited | 2009-10-08 | 29 | 0 |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND S | Well-Life Healthcare Limited | 2009-04-10 | 262 | 0 |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-220 | Well-Life Healthcare Limited | 2009-01-30 | 25 | 0 |
| K080304 | PRO TENS, MODEL WL-240 RX | Well-Life Healthcare Limited | 2008-06-20 | 136 | 0 |
| K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2 | Well-Life Healthcare Limited | 2007-12-19 | 135 | 0 |
| K063660 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 | Well-Life Healthcare Limited | 2007-02-07 | 61 | 0 |
| K052785 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 | Well-Life Healthcare Limited | 2006-03-17 | 165 | 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