510(k) K202839
K202839 is an FDA 510(k) premarket notification submitted by Jkh Health Co., Ltd. for the device "Overlapped Compression Therapy". The FDA issued a decision of Substantially Equivalent on January 21, 2021. 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
- January 21, 2021
- Date Received
- September 25, 2020
- 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