FDA UDI In Commercial Distribution 🇺🇸 United States

TENS MAKER

DI: 04719880810000 · Model: WT-110 · HIVOX BIOTEK INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TENS MAKER
Primary DI
04719880810000
Version / Model
WT-110
Company Name
HIVOX BIOTEK INC.
Labeler DUNS
658030473
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-26
Public Version
2
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
ece03322-2016-472b-b36c-3f73824631ad

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 04719880810000