DEVICE: Heartway Medical Products Co., Ltd (04719871230190)
Device Identifier (DI) Information
Heartway Medical Products Co., Ltd
S19
In Commercial Distribution
HEARTWAY MEDICAL PRODUCTS CO., LTD.
S19
In Commercial Distribution
HEARTWAY MEDICAL PRODUCTS CO., LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45684 | Assistive scooter, electric-motor-driven |
A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
INI | Vehicle, Motorized 3-Wheeled |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150987 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
820fa3d0-553d-4080-ae1d-dbce3bce6186
April 04, 2023
4
September 05, 2016
April 04, 2023
4
September 05, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined