Duns Number:030930079
Device Description: Designed with quality and durability in mind, the Active Health Labs TENS Electronic Pulse 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
Catalog Number
-
Brand Name
Active Health Labs TENS Electronic Pulse Massager
Version/Model Number
PL-109
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
304d8b02-ed10-421b-8db0-f690bc837540
Public Version Date
July 23, 2020
Public Version Number
3
DI Record Publish Date
March 16, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |