Well-Life Healthcare Limited: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Well-Life Healthcare Limited” (first 2006, latest 2024), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 142 days. Since 2017 the median was 148 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 | 1 | 126 |
| 2013 | 1 | 283 |
| 2014 | 2 | 116 |
| 2015 | 0 | — |
| 2016 | 1 | 193 |
| 2017 | 2 | 72 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 419 |
| 2022 | 3 | 148 |
| 2023 | 0 | — |
| 2024 | 1 | 389 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Well-Life Healthcare Limited took a median 148 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 |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 11 | 11 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 | 3 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| LIH | Interferential Current Therapy | 2 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Well-Life Healthcare Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | NUH | 2024-10-18 | 389 |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | KPI | 2022-12-29 | 129 |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | NUH | 2022-08-04 | 162 |
| K213091 | Well-Life TENS/EMS/Heating Stimulator | NUH | 2022-02-19 | 148 |
| K200942 | Well-Life Garment Electrodes (GM Series) | GXY | 2021-06-01 | 419 |
| K172809 | OTC Combo TENS/EMS System | NUH | 2017-10-18 | 30 |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | GZJ | 2017-01-17 | 113 |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | NUH | 2016-12-05 | 193 |
| K141299 | OTC COMBO TENS/EMS SYSTEM | NUH | 2014-11-14 | 179 |
| K133723 | OTC PATCH | NUH | 2014-01-28 | 53 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Well-Life Healthcare Limited.
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 Well-Life Healthcare Limited (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Well-Life Healthcare, Inc. (7 510(k)s)
- Well-Life Consultant (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Well-Life Healthcare Limited?
FDA lists 22 510(k) clearances under the applicant name “Well-Life Healthcare Limited” (first 2006, latest 2024), across 6 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 Well-Life Healthcare Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Well-Life Healthcare Limited is 142 days. Since 2017: 148 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Well-Life Healthcare Limited?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 11); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 3).
Next steps
- See all 22 Well-Life Healthcare Limited clearances with predicates and recalls
- Run predicate analysis for product code NUH, Well-Life Healthcare Limited'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.