Air Relax
by Maxstar Industrial Co., Ltd.
510(k) K173158
Air Relax is a medical device (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Maxstar Industrial Co., Ltd., cleared under FDA 510(k) K173158 on 30 May 2019, 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 | NumberK173158 | Date30 May 2019 | StatusActive |
Official records
- FDA 510(k) database K173158
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- Withdrawn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
Devices cleared under K173158
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AIR RELAX 8100N | 8100N | 08809040526691 | — | On the market |
| AIR RELAX 8100N-S2 | 8100N-S2 | 08809040526707 | — | On the market |
| AIR RELAX 8100N-S3 | 8100N-S3 | 08809040526714 | — | On the market |
| AIR RELAX 8100N-S4 | 8100N-S4 | 08809040526721 | — | On the market |
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