FDA UDI In Commercial Distribution 🇺🇸 United States

PowerDot

DI: 00810036056168 · Model: PowerDot PD-01M2 · Theragun, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PowerDot
Primary DI
00810036056168
Version / Model
PowerDot PD-01M2
Company Name
Theragun, Inc
Labeler DUNS
080550811
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-04-18
Public Version
2
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
f8cb29ea-6225-4ebf-bc89-8878f6cd7913

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
Yes
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

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00810036056168