FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Cala ONE
K Number: DEN170028
·
Decision Apr 26, 2018
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
7
Review Days
344
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Basic Information
- Device Name
- Cala ONE
- K Number
- DEN170028
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5897
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Cala Health, Inc.
- Date Received
- May 17, 2017
- Decision Date
- April 26, 2018
- 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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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 |
| K203288 | Cala Trio | Oct 5, 2021 | Substantially Equivalent |
| K182706 | External upper limb tremor stimulator | Oct 25, 2018 | Substantially Equivalent |