Cala Health
GUDID 00851749007177
STIMULATOR-J
CALA HEALTH, INC.
Tremor-suppression transcutaneous electrical stimulation wristband| Primary Device ID | 00851749007177 |
| NIH Device Record Key | 1d3ee137-562d-40fa-bf00-4b1f3b654b3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cala Health |
| Version Model Number | TLA-3221 |
| Company DUNS | 078877556 |
| Company Name | CALA HEALTH, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851749007177 [Primary] |
FDA Product Code
| QBC | External Upper Limb Tremor Stimulator |
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 | 2020-09-24 |
| Device Publish Date | 2020-09-16 |
Devices Manufactured by CALA HEALTH, INC.
| 00851749007412 - Cala kIQ | 2023-06-20 Stimulator |
| 00851749007429 - Cala kIQ | 2023-06-20 Base Station |
| 00851749007436 - Cala kIQ | 2023-06-20 Cala kIQ Band, Small |
| 00851749007443 - Cala kIQ | 2023-06-20 Cala kIQ Band, Medium |
| 00851749007450 - Cala kIQ | 2023-06-20 Cala kIQ Band, Large |
| 00851749007283 - Cala Trio | 2021-10-01 Trio Band-Small Left Final Assembly-Gen 3 |
| 00851749007290 - Cala Trio | 2021-10-01 Trio Band-Small Right Final Assembly-Gen 3 |
| 00851749007306 - Cala Trio | 2021-10-01 Trio Band-Medium Right Final Assembly-Gen 3 |
Trademark Results [Cala Health]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALA HEALTH 86556414 5050575 Live/Registered |
Cala Health, Inc. 2015-03-06 |
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