Maxems, Models 1000 and 2000
510(k) K091248
Maxems, Models 1000 and 2000 is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Bio Protech Inc., cleared under FDA 510(k) K091248 on 30 Nov 2009, 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 | NumberK091248 | Date30 Nov 2009 | StatusActive |
Official records
- FDA 510(k) database K091248
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- FDA applicant
- Bio Protech, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K091248
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 | |||
|---|---|---|---|---|
| Bio Protech MaxEMS 1k | MaxEMS 1k | 00817120020074 | — | On the market |
| Bio Protech MaxEMS 2k | MaxEMS 2k | 00817120020081 | — | On the market |
| MediMax Tech Innostim Combo Unit | Innostim Combo Unit | 00817325022101 | — | On the market |
| MediMax Tech Innostim EMS 1k Unit | Innostim EMS 1k Unit | 00817325020718 | — | On the market |
| MediMax Tech Innostim EMS 2k Unit | Innostim EMS 2k Unit | 00817325020725 | — | On the market |
| MediMax Tech Innostim IF 1000 Unit | Innostim IF 1000 Unit | 00817325021661 | — | On the market |
Similar devices
Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).
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- TTI REHABILATATION GYM SYS by Therapeutic Technologies, Inc.
- FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR by Famidoc Technology Co., Ltd.
- RICH-MAR CONDUCTIVE GEL by Rich-Mar Corp.