COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM— 510(k) K120166
Substantially EquivalentWon Industrial Co.
FDA 510(k) clearance K120166 for COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, Substantially Equivalent on 2012-05-14. Applicant: Won Industrial Co.. Device class: 2.
Clearance details
- Applicant
- Won Industrial Co.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code IRP
view allMore clearances from Won Industrial Co.
view allRecalls naming K120166
K-number listed on FDA's recall record- Z-0204-2018 — Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
- Z-0205-2018 — Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120166.
Data sourced from openFDA. This site is unofficial and independent of the FDA.