Air compression Leg Massager (MM0520, MM0521, MM0522)
FDA 510(k) clearance K240373 · decided 2024-09-17
Clearance details
- K-number
- K240373
- Device name
- Air compression Leg Massager (MM0520, MM0521, MM0522)
- Applicant
- Zhangzhou Easepal Medical Science and Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-07
- Decision date
- 2024-09-17
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Zhangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.