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#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233054000Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorWell-Life Healthcare Limited2024-10-18NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872264132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872264132047198722641324719872264132

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn 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 table
Primary DIBrandModelCatalogPublished
04719872263029Well-LifeWL-2306E2026-03-30
04719872264040Well-LifeWL-24062026-03-30
04719872264125Well-LifeWL-2405K+2026-03-30
04719872260028WELL-LIFECM-50502017-05-02
04719872260073WELL-LIFESP-51812017-05-02
04719872264088WELL-LIFEWL-2407Rx2017-08-07
04719872261025WELL-LIFEWL-21022017-04-26
04719872261032WELL-LIFEWL-21032017-04-26
04719872261049WELL-LIFEWL-21042017-04-26
04719872262039WELL-LIFEWL-22032017-04-26
04719872262046WELL-LIFEWL-22042017-04-26
04719872262053WELL-LIFEWL-22052017-04-26
04719872263012WELL-LIFEWL-23012017-04-25
04719872264057WELL-LIFEWL-24052017-04-25
04719872264064WELL-LIFEWL-24062017-04-25
04719872264071WELL-LIFEWL-24072017-04-25
04719872265047WELL-LIFEWL-25042017-03-29
04719872266051WELL-LIFEWR-26052017-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
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