FDA.reportPublic FDA data

e-vive NMES Electrode Set w/out Backing

Primary DI
00854816006950
Brand
e-vive NMES Electrode Set w/out Backing
Company
CYMEDICA ORTHOPEDICS, INC.
Model
CY-1000-038
Catalog number
CY-1000-038
Device description
e-vive NMES Electrode Set w/out Backing
Published
2018-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854816006950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854816006950008548160069508548160069500854816006950

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4806642547jackie.c@cymedicaortho.com

Regulatory Flags#

DUNS number
035596579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022650000e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)CY-1000-307ICY-1000-307I2021-01-04
00850022650017e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)CY-1000-308ICY-1000-308I2021-01-04
00850022650024e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)CY-1000-309ICY-1000-309I2021-01-04
00850022650031e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)CY-1000-310ICY-1000-310I2021-01-04
00850022650048e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)CY-1000-311ICY-1000-311I2021-01-04
00850022650055e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)CY-1000-312ICY-1000-312I2021-01-04
00850022650062e-vive II NMES System; S/M, Right (ITALIAN)CY-1000-313ICY-1000-313I2021-01-04
00850022650079e-vive II NMES System; L/XL, Right (ITALIAN)CY-1000-314ICY-1000-314I2021-01-04
00850022650086e-vive II NMES System; 2XL/3XL, Right (ITALIAN)CY-1000-315ICY-1000-315I2021-01-04
00850022650093e-vive II NMES System; S/M, Left (ITALIAN)CY-1000-316ICY-1000-316I2021-01-04
00850022650109e-vive II NMES System; L/XL, Left (ITALIAN)CY-1000-317ICY-1000-317I2021-01-04
00850022650116e-vive II NMES System; 2XL/3XL, Left (ITALIAN)CY-1000-318ICY-1000-318I2021-01-04
00854691008803e-vive II NMES SystemCY-1000-307CY-1000-3072021-01-04
00854691008810e-vive II NMES System CY-1000-308CY-1000-3082021-01-04
00854691008827e-vive II NMES SystemCY-1000-309CY-1000-3092021-01-04
00854691008834e-vive II NMES System CY-1000-310CY-1000-3102021-01-04
00854691008841e-vive II NMES SystemCY-1000-311CY-1000-3112021-01-04
00854691008858e-vive II NMES System CY-1000-312CY-1000-3122021-01-04
00854691008865e-vive II NMES SystemCY-1000-313CY-1000-3132021-01-04
00854691008872e-vive II NMES SystemCY-1000-314CY-1000-3142021-01-04

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