WELL-LIFE

GUDID 04719872266051

This device is a TENS/EMS Stimulator via using wireless thnology

WELL-LIFE HEALTHCARE LTD.

Physical therapy electrical stimulation system, line-powered

• Primary Device ID: 04719872266051
• NIH Device Record Key: f3804912-2acd-4ac8-84f7-6e9d97755cf8
• Commercial Distribution Discontinuation: 2019-03-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WELL-LIFE
• Version Model Number: WR-2605
• 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	04719872266051 [Primary]
GS1	94719872266054 [Package]; Package: [20 Units]; Discontinued: 2017-02-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161453

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

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: 2019-03-15
• Device Publish Date: 2017-03-15

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