510(k) K240011
K240011 is an FDA 510(k) premarket notification submitted by Jkh Health Co., Ltd. for the device "Lymphedema Compression". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Jkh Health Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2024
- Date Received
- January 2, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type