ParaMotion
FDA 510(k) clearance K203761 · decided 2022-01-21
Clearance details
- K-number
- K203761
- Device name
- ParaMotion
- Applicant
- Powerbasetec GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-12-23
- Decision date
- 2022-01-21
- Days to decision
- 394 days
- Clearance type
- Traditional
- Product code
- IPL
- Device class
- 2
- Regulation number
- 890.3900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Bodensee, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.