FDA UDI In Commercial Distribution 🇺🇸 United States

Equate

DI: 06970742221428 · Model: P.T.S-II · Guangzhou Xinbo Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Equate
Primary DI
06970742221428
Version / Model
P.T.S-II
Company Name
Guangzhou Xinbo Electronic Co., Ltd.
Labeler DUNS
530683813
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-01
Public Version
4
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
9dff2326-91bd-4896-8cee-67fb16b74cd2

Device Description

Equate Pain Therapy This is intended for the relief of pain associated with sore or aching muscles in the following anatomical locations: the lower back, shoulders, arms and legs due to strain from exercise or ADL’s (activities of daily living) principally regular household and work activities.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
No
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 06970742221428