WELL-LIFE

GUDID 04719872264057

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)

WELL-LIFE HEALTHCARE LTD.

Physical therapy electrical stimulation system, line-powered

• Primary Device ID: 04719872264057
• NIH Device Record Key: 2abc1a23-3eec-409c-a93c-2995c81d5804
• Commercial Distribution Discontinuation: 2019-04-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WELL-LIFE
• Version Model Number: WL-2405
• Company DUNS: 658608864
• Company Name: WELL-LIFE HEALTHCARE LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872264057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141299

FDA Product Code

• LIH: Interferential Current Therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-25
• Device Publish Date: 2017-04-25

On-Brand Devices [WELL-LIFE]

• 04719872266051: This device is a TENS/EMS Stimulator via using wireless thnology
• 04719872265047: Digital buttons controlled stimulator, with multiple modalities, optional 2 or 4 channels. Thi
• 04719872264088: Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS
• 04719872264071: ● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device)
• 04719872264064: ● It is intended for temporary relief of pain associated with sore and aching muscles in the l
• 04719872264057: For temporary relief of pain associated with sore and aching muscles in the lower back due to st
• 04719872263012: OTC Mini Patch, models: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators and inte
• 04719872262053: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic re
• 04719872262046: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic re
• 04719872262039: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic re
• 04719872261049:  Well-Life Powered Muscle Stimulator , analog type.  Intended for: • Relax muscle spas
• 04719872261032: Well-Life Analog electrical nerve stimulator , with BCM mode, and timer ( optional) . Intended f
• 04719872261025: Well-Life Analog electrical nerve stimulator , with BCM mode, and timer ( optional) . Intended f
• 04719872260073: The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a dispo
• 04719872260028: The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a dispo