Cala Health
Stimulator-J
1manufacturer
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fasikl Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
Record
| Listed by | Cala Health, Inc., United States |
|---|---|
| FDA product code | QBC |
| Device type | External Upper Limb Tremor Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5897 |
| Establishment | Manufacturer |
| Record published | 2020-09-16 |
| Record revised | 2023-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment atmospheric pressure 70 to 101 KiloPascal; Handling environment humidity 0 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TLA-3221 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cala Trio | Cala Health, Inc. | 21 |
| Felix NeuroAI | Fasikl Incorporated | 21 |
| Cala kIQ | Cala Health, Inc. | 11 |
| Cala kIQ Plus | Cala Health, Inc. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253587 | 2026-03-17 |
| K243848 | 2025-01-16 |
| K242259 | 2024-11-22 |
| K222237 | 2022-11-22 |
| K203288 | 2021-10-05 |
| K182706 | 2018-10-25 |
| DEN170028 | 2018-04-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.