Well-Life Healthcare, Inc.: FDA clearances and approvals
Well-Life Healthcare, Inc. has 7 FDA 510(k) clearances (first 2002, latest 2026), across 3 product codes in 3 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 248 |
Review time against the same product codes
Since 2017, Well-Life Healthcare, Inc.'s cleared 510(k)s took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Well-Life Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | KPI | 2026-02-12 | 248 |
| K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 | GZJ | 2004-05-27 | 90 |
| K033857 | T-TECH DIGITAL, MODEL WL-22XXA SERIES | GZJ | 2003-12-19 | 8 |
| K030537 | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B | GZJ | 2003-03-20 | 28 |
| K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) | GZJ | 2002-12-30 | 361 |
| K021359 | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 | GZJ | 2002-04-30 | 90 |
| K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 | IPF | 2002-04-30 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Well-Life Healthcare, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Well-Life Healthcare, Inc.'s product codes (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 does Well-Life Healthcare, Inc. have?
Well-Life Healthcare, Inc. has 7 FDA 510(k) clearances (first 2002, latest 2026), across 3 product codes in 3 review panels.
How long does FDA take to clear Well-Life Healthcare, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Well-Life Healthcare, Inc.'s cleared 510(k)s is 90 days.
What devices does Well-Life Healthcare, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 5); IPF (Stimulator, Muscle, Powered, 1); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1).
Has Well-Life Healthcare, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Well-Life Healthcare, Inc. Related entities may recall under other names.
Next steps
- See all 7 Well-Life Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Well-Life Healthcare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.