FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
8ch Knee-Foot SPEEDER
K Number: K162946
·
Decision Jan 6, 2017
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
21
Review Days
77
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Basic Information
- Device Name
- 8ch Knee-Foot SPEEDER
- K Number
- K162946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quality Electrodynamics, LLC
- Date Received
- October 21, 2016
- Decision Date
- January 6, 2017
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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Other Clearances by Quality Electrodynamics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242006 | SureWave Elastography (Q7000225) | Feb 12, 2025 | Substantially Equivalent |
| K223429 | Contour Knee | Jan 13, 2023 | Substantially Equivalent |
| K200477 | Flex Body Speeder | Apr 8, 2020 | Substantially Equivalent |
| K193140 | Flex Body SPEEDER | Jan 3, 2020 | Substantially Equivalent |
| K183111 | Contour 24 | Dec 7, 2018 | Substantially Equivalent |
| K181697 | 16ch Foot/ Ankle SPEEDER | Jul 11, 2018 | Substantially Equivalent |
| K173469 | 16ch T/R Hand Wrist Coil | Jan 9, 2018 | Substantially Equivalent |
| K173446 | Contour 24 | Nov 17, 2017 | Substantially Equivalent |
| K162623 | 16ch T/R Hand Wrist Coil | Dec 9, 2016 | Substantially Equivalent |
| K162966 | TxRx Knee 15 Flare MR Coil 1.5T | Nov 30, 2016 | Substantially Equivalent |