FDA.report

E.M Adams co, inc.

Primary DI
50840200307418
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
EP26-63391-1
Device description
BELT
Published
2021-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50840200307418PackageGS148In Commercial Distribution
10840200307427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5084020030741850840200307418
1084020030742710840200307427

GMDN Terms

TermDefinition
Gait rehabilitation system harnessA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags

DUNS number
001403807
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
50840200325313E.M. Adams Company14-3390-12022-08-18
50840200313525E.M. ADAMS CO, INC26-0615XL-12022-07-17
50840200313549E.M. ADAMS CO, INC26-0615XXL-12022-07-17
50840200313563E.M. ADAMS CO, INC26-0615XXXL-12022-07-17
50840200313587E.M. ADAMS CO, INC26-0615XXXXL-12022-07-17
50840200313624E.M. ADAMS CO, INC26-0644-12022-07-17
50840200313648E.M. ADAMS CO, INC26-0654-12022-07-17
50840200314744E.M. ADAMS CO, INCEP28-30205B-12022-07-17
50840200314768E.M. ADAMS CO, INCEP28-30205G-12022-07-17
50840200314782E.M. ADAMS CO, INCEP28-30205U-12022-07-17
50840200314805E.M. ADAMS CO, INCEP28-30206B-12022-07-17
50840200314843E.M. ADAMS CO, INCEP28-30206U-12022-07-17
50840200314867E.M. ADAMS CO, INCEP28-30207B-12022-07-17
50840200314881E.M. ADAMS CO, INCEP28-30207G-12022-07-17

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