Cala Trio
Trio Band-Medium Right Final Assembly-Gen 3
1manufacturer
21catalogue numbers in this listing
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 | 2021-09-23 |
| Record revised | 2023-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Storage environment atmospheric pressure 70 to 101 KiloPascal; Storage environment humidity 0 to 90 % RH |
| Sizes | Length 136 to 204 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TLA-3264 | Length 164 mm | In distribution |
| TLA-3158 | Length 136 mm | In distribution |
| TLA-3163 | Length 204 mm | In distribution |
| TLA-3193 | Length 136 mm | In distribution |
| TLA-3194 | Length 136 mm | In distribution |
| TLA-3160 | Length 164 mm | In distribution |
| TLA-3196 | Length 164 mm | In distribution |
| TLA-3206 | In distribution | |
| TLA-3179 | In distribution | |
| TLA-3263 | Length 136 mm | In distribution |
| TLA-3262 | Length 136 mm | In distribution |
| TLA-3161 | Length 164 mm | In distribution |
| TLA-3162 | Length 204 mm | In distribution |
| TLA-3159 | Length 136 mm | In distribution |
| TLA-3265 | Length 164 mm | In distribution |
| TLA-3197 | Length 204 mm | In distribution |
| TLA-3140 | In distribution | |
| TLA-3195 | Length 164 mm | In distribution |
| TLA-3267 | Length 204 mm | In distribution |
| TLA-3198 | Length 204 mm | In distribution |
| TLA-3266 | Length 204 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Felix NeuroAI | Fasikl Incorporated | 21 |
| Cala kIQ | Cala Health, Inc. | 11 |
| Cala kIQ Plus | Cala Health, Inc. | 2 |
| Cala Health | Cala Health, Inc. | 1 |
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.