DEVICE: EasyStand (10858921006062)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 61702 | Electric stander |
An electrically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, digestion, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad) and an electrically-powered lifting mechanism to raise the patient from a supine, prone, and/or seated position to standing. It includes wheels for reorientation.
|
Active | false |
| 61701 | Pneumatic stander |
A pneumatically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, digestion, and flexibility); it is not intended to facilitate gait. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), a compressed gas cylinder, and a pneumatic lifting mechanism to raise the patient from a supine, prone, and/or seated position to standing. It includes wheels for reorientation and may include a manual mechanism to allow the occupant a degree of mobility.
|
Active | false |
| 61700 | Manual stander |
A manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| INO | Chair, Positioning, Electric |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K091242 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f80a9d94-da7a-4ac8-a141-0dece894ed0a
August 05, 2022
4
September 19, 2016
August 05, 2022
4
September 19, 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 |
|---|---|
| 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