Duns Number:569403736
Device Description: Pain Aide is a TENS device which is commonly used to provide relief from pain associated w Pain Aide is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.It has four preset programs specially designed to alleviate pain in different parts of the body. Pain Aide is designed to be easy to use, but has professional grade features like small 1 mA intensity steps, open-circuit detection with cutout, automatic keypad locking, and back-lit display. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.
Catalog Number
K-PA
Brand Name
Pain Aide
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
4bf39cb9-f214-486e-83d6-f2581feb6fc7
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
November 12, 2018
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. | 7 |