DEVICE: Hi-Fortune (06973852590040)

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Device Record History
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Device Identifier (DI) Information
Hi-Fortune
HM03MS
In Commercial Distribution

Kunshan Hi-Fortune Health Products Co.,Ltd
06973852590040
GS1

1
548310008 *Terms of Use
Weight: 10.5kg, L745mm*W325mm*H760mm
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
58086 All-plastic conventional wheelchair
An all-plastic wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (non-bariatric) and designed to be manually propelled by the occupant while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. It contains no metal parts and may be safely used in magnetic resonance imaging (MRI) environments and security scanners, submersed in water (e.g., swimming pool, balneotherapy), and used in a shower. The device cannot be folded or readily dismantled for transport.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
IMN Climber, Curb, Wheelchair
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
82ff87cc-a10d-4314-b0a0-1ac0ce3c9777
November 01, 2021
1
October 23, 2021
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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