Duns Number:004416769
Device Description: Therapist’s Choice® TENS2N1 Combo: It is used for temporary relief of pain associated wit Therapist’s Choice® TENS2N1 Combo: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip,upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Catalog Number
TENS2N1 Combo
Brand Name
Therapist’s Choice® TENS2N1 Combo
Version/Model Number
TENS2N1 Combo
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
b45001ba-f357-4120-b6a0-0d75fee3e9e2
Public Version Date
February 24, 2022
Public Version Number
1
DI Record Publish Date
February 16, 2022
Package DI Number
10815290018478
Quantity per Package
32
Contains DI Package
00815290018471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |