FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CoolTone
K Number: K253408
·
Decision Jan 16, 2026
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
13
Review Days
108
Basic Information
- Device Name
- CoolTone
- K Number
- K253408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer Medizinsysteme GmbH
- Date Received
- September 30, 2025
- Decision Date
- January 16, 2026
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Zimmer Medizinsysteme GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K251378 | CoolTone | Jul 14, 2025 | Substantially Equivalent |
| K240347 | PTG-05 | Jul 21, 2024 | Substantially Equivalent |
| K240178 | RFG-01 | Jul 15, 2024 | Substantially Equivalent |
| K230780 | MFG-05 | Oct 5, 2023 | Substantially Equivalent |
| K213256 | ThermoTK | May 25, 2023 | Substantially Equivalent |
| K222912 | c1Trac | May 16, 2023 | Substantially Equivalent |
| K220601 | CoolTone | Apr 1, 2022 | Substantially Equivalent |
| K220020 | Cryo 7 | Feb 4, 2022 | Substantially Equivalent |
| K203488 | emField | Feb 19, 2021 | Substantially Equivalent |
| K192940 | CoolTone | Nov 15, 2019 | Substantially Equivalent |