EconoStim
GUDID 00851913006210
2" x 2" (5cm x 5cm) Square
AXELGAARD MANUFACTURING CO., LTD.
Transcutaneous electrical stimulation electrode| Primary Device ID | 00851913006210 |
| NIH Device Record Key | f0bb42e6-9219-4301-a751-3806a792de14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EconoStim |
| Version Model Number | ESB5050 |
| Company DUNS | 150959401 |
| Company Name | AXELGAARD MANUFACTURING CO., LTD. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com | |
| Phone | 760-451-8000 |
| customerservice@axelgaard.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851913006210 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130987
FDA Product Code
| GXY | Electrode, Cutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-15 |
| Device Publish Date | 2020-01-07 |
On-Brand Devices [EconoStim]
| 00851913006227 | 2" x 4" (5cm x 10cm) Rectangle |
| 00851913006210 | 2" x 2" (5cm x 5cm) Square |
| 00851913006203 | 2" (5 cm) Round |
| 00851913006197 | 1.2" x 2" (3cm x 5cm) Rectangle |
Trademark Results [EconoStim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECONOSTIM 86478308 4919258 Live/Registered |
Axelgaard Manufacturing Co., Ltd. 2014-12-11 |
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