DEVICE: E.M Adams co, inc. (18100013407342)

Device Identifier (DI) Information

E.M Adams co, inc.
EP26-63340XL-1
Not in Commercial Distribution

E.M. ADAMS, INC.
18100013407342
GS1
February 28, 2021
1
001403807 *Terms of Use
BELT
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Gait rehabilitation system harness A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.
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FDA Product Code

[?]
Product Code Product Code Name
IKX Aid, Transfer
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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
Device Size Text, specify: 2" X 72" BELT
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Device Record Status

f2a4e61f-1868-4ed1-afec-efd847840e7b
March 01, 2021
3
December 31, 2019
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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
58100013407333 48 18100013407342 2021-02-28 Not in Commercial Distribution Case
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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
No
No
No CLOSE

Customer Contact

[?]
+1(772)461-0532
EMADAMS@EMADAMSCO.COM
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