FDA.reportPublic FDA data

WELL-LIFE

Primary DI
04719872264057
Brand
WELL-LIFE
Company
WELL-LIFE HEALTHCARE LTD.
Model
WL-2405
Device description
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7)For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8)For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)
Published
2017-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141299000OTC COMBO TENS/EMS SYSTEMWell-Life Healthcare Limited2014-11-14NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872264057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872264057047198722640574719872264057

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658608864
Device count
1
DM exempt
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
04719872264132Well-LifeWL-2405H(M)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
04719872264064WELL-LIFEWL-24062017-04-25
04719872264071WELL-LIFEWL-24072017-04-25
04719872265047WELL-LIFEWL-25042017-03-29
04719872266051WELL-LIFEWR-26052017-03-15

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