FDA UDI In Commercial Distribution 🇺🇸 United States

Flint Rehab

DI: G144FM0 · Model: FM · Flint Rehabilitation Devices LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Flint Rehab
Primary DI
G144FM0
Version / Model
FM
Company Name
Flint Rehabilitation Devices LLC
Labeler DUNS
078285646
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-10
Public Version
1
Public Version Date
2023-08-18
Public Version Status
New
Public Device Record Key
ac3b32bf-79a2-4dfb-b5b4-c691e590fdb9

Device Description

FitMi Exercise System

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ION Exerciser, Non-Measuring

GMDN Terms

Code Name
30908 Perceptual-coordination assistive training device

Identifiers

Type ID
Primary G144FM0