Atlas FDA

GENESIS (MS-P02-GEN)

FDA 510(k) clearance K240843 · decided 2024-10-07

Clearance details

K-number
K240843
Device name
GENESIS (MS-P02-GEN)
Applicant
Climbing Steps, Inc.
Decision
Substantially Equivalent
Date received
2024-03-27
Decision date
2024-10-07
Days to decision
194 days
Clearance type
Traditional
Product code
ILK
Device class
2
Regulation number
890.5150
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Brooklyn, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.