FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
emField
K Number: K203488
·
Decision Feb 19, 2021
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
13
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- emField
- K Number
- K203488
- 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
- November 27, 2020
- Decision Date
- February 19, 2021
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPF), ordered by most recent decision date.
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·Physical Medicine
High Tone Power therapy (HiToP) (Model: HiToP PNP)
FDA 510(k)
FDA Class 2
·Physical Medicine
StimelMD (SSMD) system
FDA 510(k)
FDA Class 2
·Physical Medicine
Compact II
FDA 510(k)
FDA Class 2
·Physical Medicine
EVE Synergy (EVE-20M)
FDA 510(k)
FDA Class 2
·Physical Medicine
TrainFES Advance
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Zimmer Medizinsysteme GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K253408 | CoolTone | Jan 16, 2026 | Substantially Equivalent |
| 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 |
| K192940 | CoolTone | Nov 15, 2019 | Substantially Equivalent |