FDA.report

Addaday

Primary DI
20860001326806
Brand
Addaday
Company
ADDADAY LLC
Model
EMS Type A
Catalog number
8081
Device description
A patented ultra-thin design equipped with advanced EMS program. Electrical stimulation activates muscle self-exercising. Wireless & Portable. 15 Intensity Levels. one-piece structure EMS device. Exercise with 3 cycles for 20 minutes. Adjustable Stimulation Intensity. Muscle recovery & performance tool.
Published
2019-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10860001326809PackageGS140In Commercial Distribution
20860001326806PackageGS14In Commercial Distribution
00860001326802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000132680910860001326809
2086000132680620860001326806
00860001326802008600013268028600013268020860001326802

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
310.905.2737po@addaday.com

Regulatory Flags

DUNS number
066512101
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860001326819AddadayEMS Type B80822019-03-07
20860001326820AddadayEMS Type C80832019-03-07
00860001326833AddadayEMS Type D80842019-03-07

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