Tm-400
510(k) K081247
Tm-400 is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K081247 on 25 Aug 2008, 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 | NumberK081247 | Date25 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081247
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITH
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K081247
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 | |||
|---|---|---|---|---|
| TM-400 | TM-400 / TM-400 | 04983087007932 | — | On the market |
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