FDA UDI In Commercial Distribution 🇺🇸 United States

Healing Innovations

DI: 00860003483206 · Model: RWC1000 · Healing Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Healing Innovations
Primary DI
00860003483206
Version / Model
RWC1000
Company Name
Healing Innovations, Inc.
Labeler DUNS
071390002
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-08
Public Version
1
Public Version Date
2023-09-18
Public Version Status
New
Public Device Record Key
d48b444f-e22c-4f60-bc42-16e00006c07c

Device Description

robotic neurorehabilitation device for gait training and additional therapy purposes

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
Yes
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
IKK System, Isokinetic Testing And Evaluation

GMDN Terms

Code Name
58875 Gait rehabilitation frame, electric

Identifiers

Type ID
Primary 00860003483206