FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cala Trio
K Number: K203288
·
Decision Oct 5, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
7
Review Days
330
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Basic Information
- Device Name
- Cala Trio
- K Number
- K203288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5897
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cala Health, Inc.
- Date Received
- November 9, 2020
- Decision Date
- October 5, 2021
- Product Code
- QBC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QBC | External Upper Limb Tremor Stimulator | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBC), ordered by most recent decision date.
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FDA Class 2
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Other Clearances by Cala Health, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253587 | Cala kIQ Plus | Mar 17, 2026 | Substantially Equivalent |
| K243848 | Cala kIQ | Jan 16, 2025 | Substantially Equivalent |
| K242259 | Cala kIQ | Nov 22, 2024 | Substantially Equivalent |
| K222237 | Cala kIQ | Nov 22, 2022 | Substantially Equivalent |
| K182706 | External upper limb tremor stimulator | Oct 25, 2018 | Substantially Equivalent |
| DEN170028 | Cala ONE | Apr 26, 2018 | Unknown |