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 Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system 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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