FDA.reportPublic FDA data

WELL-LIFE

Primary DI
04719872266051
Brand
WELL-LIFE
Company
WELL-LIFE HEALTHCARE LTD.
Model
WR-2605
Device description
This device is a TENS/EMS Stimulator via using wireless thnology
Published
2017-03-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
NGYCannula, Trocar, Ophthalmic
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGYCannula, Trocar, OphthalmicOphthalmic1
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161453000WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited2016-12-05NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
94719872266054PackageGS120Not in Commercial Distribution
04719872266051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
9471987226605494719872266054
04719872266051047198722660514719872266051

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
04719872264057WELL-LIFEWL-24052017-04-25
04719872264064WELL-LIFEWL-24062017-04-25
04719872264071WELL-LIFEWL-24072017-04-25
04719872265047WELL-LIFEWL-25042017-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
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06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
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06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
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