FDA UDI Not in Commercial Distribution 🇺🇸 United States

NURSAL

DI: 06970890320066 · Model: AS1080 · Shenzhen As-Tec Technology Co.,Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NURSAL
Primary DI
06970890320066
Version / Model
AS1080
Company Name
Shenzhen As-Tec Technology Co.,Ltd.
Labeler DUNS
421355284
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-29
Public Version
11
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
294fbc4c-feac-4b18-9cec-194ee3923e20
Distribution End Date
2021-03-11

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Package 06970890327065
Primary 06970890320066

Premarket Submissions

Submission Number Supplement Number
K143268 000