CycloTens Starter Pak
GUDID 20370914012005
Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable and one bottle of 30ct. Cyclobenzaprine 10mg
HUDSON SCIENTIFIC, LLC
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 20370914012005 |
| NIH Device Record Key | ae90a744-ed7d-4065-a164-2314ea9a7bc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CycloTens Starter Pak |
| Version Model Number | 50053A |
| Company DUNS | 080339637 |
| Company Name | HUDSON SCIENTIFIC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00370914012001 [Primary] |
| GS1 | 10370914012008 [Package] Contains: 00370914012001 Package: Shipper Box [10 Units] In Commercial Distribution |
| GS1 | 20370914012005 [Package] Contains: 00370914012001 Package: Case Box [120 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133979
FDA Product Code
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2017-07-24 |
Devices Manufactured by HUDSON SCIENTIFIC, LLC
| 20370914012005 - CycloTens Starter Pak | 2019-10-23Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable and one bottle of 30ct. Cyclobenzaprine 10mg |
| 20370914012005 - CycloTens Starter Pak | 2019-10-23 Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable and one bottle of 30ct. Cyclobenzaprine |
| 20370914001009 - D-Care | 2018-07-06 Glucose Monitoring Kit includes Glucose Meter, Test Strip, Lancing Device, Lancets and 7 Information Inserts. |
| 00370914003054 - D-Care | 2018-07-06 Blood Glucose Test Strips (50 count) |
| 00370914006017 - D-Care | 2018-07-06 DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips |
| 20370914013019 - CycloTens Refill Pak | 2018-07-06 One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads |
| 00370914030012 - Alzair | 2018-07-06 Alzair is a natural powder product that works by strengthening one's resistance to allergens via a nasal spray with a patented d |
Trademark Results [CycloTens Starter Pak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYCLOTENS STARTER PAK 87321031 not registered Dead/Abandoned |
Hudson Scientific, LLC 2017-02-01 |
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