Rumble Tuff
510(k) K113315
Rumble Tuff is a Class II device made by Acute Ideas Co., Ltd., cleared under FDA 510(k) K113315 on 20 Nov 2012, 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 | NumberK113315 | Date20 Nov 2012 | StatusActive |
Official records
- FDA 510(k) database K113315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HGX
- FDA applicant
- Acute Ideas Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.5160
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K113315
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 | |||
|---|---|---|---|---|
| DRIVEMEDICAL MQ9120 | MQ9120 | 00822383542942 | — | No longer on the market |
| Medquip MQ9000 | MQ9000 | 00718122644391 | — | No longer on the market |
| Rumble Tuff 200DP | 200DP | 00879388001097 | — | On the market |
| Rumble Tuff 208DU2 | 208DU2 | 00879388002889 | — | On the market |
| Rumble Tuff 208DU3 | 208DU3 | 00879388005132 | — | On the market |
| Rumble Tuff 209DA2 | 209DA2 | 00853396003625 | — | On the market |
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