AccessGUDID - DEVICE: Active Health Labs TENS Electronic Pulse Massager (00868888000303)

GUDID

Device Identifier (DI) Information

Brand Name: Active Health Labs TENS Electronic Pulse Massager
Version or Model: PL-109
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEAL NOVA LLC

Primary DI Number: 00868888000303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030930079 *Terms of Use

Device Description: Designed with quality and durability in mind, the Active Health Labs TENS Electronic Pulse Massager is the best therapeutic pain reliever on the market! Using advanced electrical muscle stimulation technology, it is the secret to reducing and relieving all sorts of pains, including muscle soreness, stiffness, injuries, arthritis, joint pain, and more. The pulse massager provides 6 auto-stimulation programs, 3 traditional massage settings, dual outputs with independent control, and adjustable speed and intensity. Control how you treat your pain, and find out what works best for you! Our design is easy to use, as all buttons and settings are clearly and simply labeled. Plus, it is compact! Weighing in at approximately 5 ounces, it is light enough to carry anywhere! Take it to the gym, on a trip, to the office, and more! Don't endure another minute of chronic pain

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
44743	Static magnetic therapeutic clothing/jewelry	A body-worn magnetized metallic device intended to be used in the home to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief from aches, pain or tension (e.g., due to arthritis, sciatica, whiplash, sports injuries, muscle soreness/stiffness, dysmenorrhea, menopause), psycho-emotional stress, and/or sleep ailments. It is available in a variety of forms (e.g., clothing, belt, insole, bracelet, necklace, ring, plate, disk, pad, mask) and may be attached to clothing or applied directly to the skin with an adhesive plaster. It is not designed as an orthosis (i.e. does not provide therapeutic body support). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 304d8b02-ed10-421b-8db0-f690bc837540
Public Version Date: May 04, 2023
Public Version Number: 4
DI Record Publish Date: March 16, 2017