Air Compression Therapy System
by Shenzhen Lifotronic Technology Co., Ltd.
510(k) K192466
Air Compression Therapy System is a medical device (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Shenzhen Lifotronic Technology Co., Ltd., cleared under FDA 510(k) K192466 on 22 Jun 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192466 | Date22 Jun 2020 | StatusActive |
Official records
- FDA 510(k) database K192466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IRP
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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