JOW — Sleeve, Limb, Compressible Class II
FDA product code JOW covers "Sleeve, Limb, Compressible", a Class II medical device regulated under 21 CFR 870.5800. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOW
- Device Class
- Class II
- Regulation Number
- 870.5800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253386 | vistar medical supplies co | DVT Garment | June 25, 2026 |
| K250242 | guangzhou longest medical technology co | Compression Therapy Device (LGT-2202DVT) | April 24, 2026 |
| K254267 | mego afek | NanoPress 760A-BT (760A-BT) | February 24, 2026 |
| K250974 | bio compression systems | Bio Arterial Deluxe (IC-BAP-DX) | December 12, 2025 |
| K250190 | shenzhen comen medical instruments co | Sequential Compression System (SCD600) | December 8, 2025 |
| K251466 | wellell | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio | October 28, 2025 |
| K251446 | manamed | PlasmaFlow X Compression Sleeve Device (XPF0001) | September 17, 2025 |
| K251086 | biotab | PnueAira (PNCU-01) | August 18, 2025 |
| K250817 | vive health | Coretech Compression System (Coretech RHB3003) | August 8, 2025 |
| K241096 | suzhou minhua medical apparatus supplies co | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | January 15, 2025 |
| K240499 | airos medical | ARTAIRA Arterial Compression Device (AACD01) | October 11, 2024 |
| K241746 | united medical resources | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES | October 4, 2024 |
| K232640 | thermabright | Venowave VW5 | June 25, 2024 |
| K234155 | tactile medical | Nimbl (model PD08-N1) | June 21, 2024 |
| K240125 | zenith technical innovations | Therm-X (Home); Therm-X (AT) | June 21, 2024 |
| K232270 | koge micro tech co | DVT Motion Pneumatic Compression Device | March 6, 2024 |
| K240011 | jkh health co | Lymphedema Compression | February 23, 2024 |
| K223228 | koya medical | Dayspring | January 4, 2024 |
| K232300 | elastimed | ElastiMed SACS | December 22, 2023 |
| K231801 | medhealth medical limited | MedHealth DVT compression Devices MHH900S/MHH900E | December 14, 2023 |