FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Legend Pro DMA
K Number: K200545
·
Decision Oct 21, 2021
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
18
Review Days
597
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Basic Information
- Device Name
- Legend Pro DMA
- K Number
- K200545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pollogen, Ltd.
- Date Received
- March 3, 2020
- Decision Date
- October 21, 2021
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Pollogen, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242227 | GENEO X ELITE | Oct 12, 2025 | Substantially Equivalent |
| K252576 | Legend X Platform | Sep 12, 2025 | Substantially Equivalent |
| K250734 | OptiLUV Device | Sep 10, 2025 | Substantially Equivalent |
| K243217 | Legend X Desktop System | Nov 1, 2024 | Substantially Equivalent |
| K240999 | Legend X Applicator VO | May 8, 2024 | Substantially Equivalent |
| K233766 | Geneo X Elite | May 7, 2024 | Substantially Equivalent |
| K232903 | Legend X Platform | Oct 17, 2023 | Substantially Equivalent |
| K220322 | Pollogen STOP U Model UXV Device | May 4, 2023 | Substantially Equivalent |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Feb 17, 2022 | Substantially Equivalent |
| K203665 | STOP U Model UXV Device | Feb 25, 2021 | Substantially Equivalent |