FDA.report

Pro Comfort Tens Unit Pads

Primary DI
00850632007218
Brand
Pro Comfort Tens Unit Pads
Company
HOME AIDE DIAGNOSTICS, INC.
Model
SM120
Catalog number
7218
Device description
2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens Unit The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment.
Published
2017-12-01
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
false

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850632007215PackageGS1160In Commercial Distribution
00850632007218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200721510850632007215
00850632007218008506320072188506320072180850632007218

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
8009150116info@homeaide.us

Regulatory Flags

DUNS number
783518983
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00850058864006True-Comfort Safety Pen Needles 4MM 32G12024-10-08
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