DEVICE: DR-HO'S (06970742221473)
Device Identifier (DI) Information
DR-HO'S
PBR-1
In Commercial Distribution
Guangzhou Xinbo Electronic Co., Ltd.
PBR-1
In Commercial Distribution
Guangzhou Xinbo Electronic Co., Ltd.
DR-HO's Perfect Back Rest
This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41566 | Back-filling orthosis |
A prefabricated (non-customized) externally applied and wearable device designed to fill in severe curvatures of the back. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IQE | Orthosis, Lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
0fa1fead-1b0e-4815-9bfc-079f322fb3ad
June 10, 2022
2
March 01, 2020
June 10, 2022
2
March 01, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined