Well-Life
- Primary DI
- 04719872264132
- Brand
- Well-Life
- Company
- WELL-LIFE HEALTHCARE LTD.
- Model
- WL-2405H(M)
- Device description
- The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relieffrom sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs)due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea(menstrual cramps) when used with over-the-counter pain medication.Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitatemuscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable painand relief from pain associated with arthritis (select TENS mode P8).
- Published
- 2026-03-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- OTC
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K233054 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K233054 | 000 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | Well-Life Healthcare Limited | 2024-10-18 | NUH |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04719872264132 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04719872264132 | 04719872264132 | 4719872264132 |
GMDN Terms#
| Term | Definition |
|---|---|
| Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. |
Regulatory Flags#
- DUNS number
- 658608864
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04719872263029 | Well-Life | WL-2306E | 2026-03-30 | |
| 04719872264040 | Well-Life | WL-2406 | 2026-03-30 | |
| 04719872264125 | Well-Life | WL-2405K+ | 2026-03-30 | |
| 04719872260028 | WELL-LIFE | CM-5050 | 2017-05-02 | |
| 04719872260073 | WELL-LIFE | SP-5181 | 2017-05-02 | |
| 04719872264088 | WELL-LIFE | WL-2407Rx | 2017-08-07 | |
| 04719872261025 | WELL-LIFE | WL-2102 | 2017-04-26 | |
| 04719872261032 | WELL-LIFE | WL-2103 | 2017-04-26 | |
| 04719872261049 | WELL-LIFE | WL-2104 | 2017-04-26 | |
| 04719872262039 | WELL-LIFE | WL-2203 | 2017-04-26 | |
| 04719872262046 | WELL-LIFE | WL-2204 | 2017-04-26 | |
| 04719872262053 | WELL-LIFE | WL-2205 | 2017-04-26 | |
| 04719872263012 | WELL-LIFE | WL-2301 | 2017-04-25 | |
| 04719872264057 | WELL-LIFE | WL-2405 | 2017-04-25 | |
| 04719872264064 | WELL-LIFE | WL-2406 | 2017-04-25 | |
| 04719872264071 | WELL-LIFE | WL-2407 | 2017-04-25 | |
| 04719872265047 | WELL-LIFE | WL-2504 | 2017-03-29 | |
| 04719872266051 | WELL-LIFE | WR-2605 | 2017-03-15 |
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| 06971712725908 | MASTOGO | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-25 |
| 00850080988657 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-07-22 |
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| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NYN | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NYN | 2026-07-09 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-07-03 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-03 |
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