Air Compression Massager (EP30B001 I)
FDA 510(k) clearance K260948 · decided 2026-07-24
Clearance details
- K-number
- K260948
- Device name
- Air Compression Massager (EP30B001 I)
- Applicant
- Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-23
- Decision date
- 2026-07-24
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Xiamen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.