510(k) clearances

Sway System Sports Plus

Sway Medical, Inc. · Neurology

K241737Substantially EquivalentTraditionalPOM
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Third party flag
N
City
Tulsa
Advisory committee description
Neurology
Address 1
32 S. Lewis Ave.
Statement or summary
Summary
Product code
POM
Zip code
74104
Applicant
Sway Medical, Inc.
Decision date
2025-02-15
Decision code
SESE
Country code
US
Device name
Sway System Sports Plus
Advisory committee
NE
Contact
Alex Pettigrew
K number
K241737
State
OK
Date received
2024-06-17
Review advisory committee
NE
Postal code
74104
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Computerized Cognitive Assessment Aid For Concussion
Medical specialty description
Neurology
Regulation number
882.1471
Device class
2
Registration number
3011279934, 3010325634, 3012102743
FEI number
3011279934, 3010325634, 3012102743
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.