FDA.reportPublic FDA data

CycloTens Starter Pak

Primary DI
00370914012001
Brand
CycloTens Starter Pak
Company
HUDSON SCIENTIFIC, LLC
Model
50053A
Device description
Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable and one bottle of 30ct. Cyclobenzaprine 10mg
Published
2017-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133979000TENSSunmas (H.K.) Trading Limited2014-08-26NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10370914012008PackageGS110In Commercial Distribution
20370914012005PackageGS1120In Commercial Distribution
00370914012001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037091401200810370914012008
2037091401200520370914012005
00370914012001003709140120013709140120010370914012001

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly 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; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
5172124047angela.powell@hudsci.com

Regulatory Flags#

DUNS number
080339637
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370914030012Alzair Allergy Blocker501312017-09-19
00370914001005D-Care50001A2017-07-24
00370914003054D-Care50003A2017-07-24
00370914006017D-Care50002A2017-07-24
20370914012005CycloTens Starter Pak50053A2017-07-24
00370914013015CycloTens Refill Pak50054A2017-07-24
20370914001009D-Care50001A2017-07-24
20370914013019CycloTens Refill Pak50054A2017-07-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03770018808086actiTENSSUBLIMEDNUH2026-05-27
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03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
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