AccessGUDID - DEVICE: WELL-LIFE (04719872262039)

GUDID

Device Identifier (DI) Information

Brand Name: WELL-LIFE
Version or Model: WL-2203
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WELL-LIFE HEALTHCARE LTD.

Primary DI Number: 04719872262039
Issuing Agency: GS1
Commercial Distribution End Date: April 26, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 658608864 *Terms of Use

Device Description: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic relief of chronic intractable pain (TENS), and EMS intended for: Relax muscle spasms/ Prevent or retard disuse atrophy/ Increase local blood circulation/ Re-educate muscles/ Maintain or increase the range of motion

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46571	Physical therapy transcutaneous electrical stimulation system, line-powered	An 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LIH	Interferential Current Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033857	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68326277-46f3-4b76-abf5-50f6ea549589
Public Version Date: May 23, 2019
Public Version Number: 5
DI Record Publish Date: April 26, 2017