Myo Plus
Otto Bock Healthcare Products GmbH
Otto Bock Healthcare Products GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005190268 | 3005190268 | Otto Bock Healthcare Products GmbH | 1 | N | 2026-01-01 | Brehmstrasse 16 Vienna Wien AT A-1110 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 147228 | 1048310480 | K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | GXY | 2026-04-22 |
| 147228 | 1832042356 | K191179 | Myo Plus | GXY | 2019-09-04 |
| 147228 | 1364577744 | K123795 | AXON-BUS PROSTHETIC SYSTEM | GXY | 2014-06-03 |
| 147228 | 1784890066 | K080950 | STIWELL MED4 | IPF | 2009-04-02 |
| 147228 | 1001344306 | ||||
| 147228 | 1042199368 | ||||
| 147228 | 1078293573 | ||||
| 147228 | 1201693662 | ||||
| 147228 | 1227841122 | ||||
| 147228 | 1449152378 | ||||
| 147228 | 1534241596 | ||||
| 147228 | 1541881978 | ||||
| 147228 | 1590505335 | ||||
| 147228 | 1781965032 | ||||
| 147228 | 1830344836 | ||||
| 147228 | 1849399171 | ||||
| 147228 | 1945459881 | ||||
| 147228 | 1953110895 | ||||
| 147228 | 2025340748 |
Product Codes Associated With Registrations#
PMN#
MYGAIT STIMULATION SYSTEM
OTTO BOCK HEALTHCARE PRODUCTS GMBH
GUDID#
Myo Plus - 560X18-1=ANDR
2026-05-04
Myo Plus - 560X18-1=IOS
2026-05-04
Myo Plus TR - 13E520
2026-05-04
Myo Plus TR - 13E520=OB
2026-05-04
myosmart. - 13E522=1
2026-05-04
myosmart.cuff - 757M20-2=50
2026-05-04
myosmart.cuff - 757M20-2=50-OB
2026-05-04
myosmart.cuff - 757M20-2=60
2026-05-04
myosmart.cuff - 757M20-2=60-OB
2026-05-04
myosmart.cuff - 757M20-2=50-S
2026-05-04
myosmart.cuff - 757M20-2=60-S
2026-05-04
myosmart trial kit - 642V64=T-SMART-OB
2026-05-04
myosmart trial kit - 642V64=T-SMART-S
2026-05-04
connectgrip. - 560X27-1=ANDR
2026-05-04
connectgrip. - 560X27-1=IOS
2026-05-04
Electrode - 13E200=50
2020-03-19
Electrode - 13E200=60
2020-03-19
Suction Socket Electrode - 13E202=50
2020-03-19
Suction Socket Electrode - 13E202=60
2020-03-19
Remote Electrode - 13E400=G140-50
2020-03-19
Remote Electrode - 13E400=G140-50-OB
2020-03-19
Remote Electrode - 13E400=G140-60
2020-03-19
Remote Electrode - 13E400=G140-60-OB
2020-03-19
Remote Electrode - 13E400=G90-50
2020-03-19
Remote Electrode - 13E400=G90-50-OB
2020-03-19
Remote Electrode - 13E400=G90-60
2020-03-19
Remote Electrode - 13E400=G90-60-OB
2020-03-19
Remote Electrode - 13E401=G140-50
2020-03-19
Remote Electrode - 13E401=G140-50-OB
2020-03-19
Remote Electrode - 13E401=G140-60
2020-03-19
Remote Electrode - 13E401=G140-60-OB
2020-03-19
Remote Electrode - 13E401=G90-50
2020-03-19
Remote Electrode - 13E401=G90-50-OB
2020-03-19
Remote Electrode - 13E401=G90-60
2020-03-19
Remote Electrode - 13E401=G90-60-OB
2020-03-19
Myo Plus trial kit - 642V64=T-PLUS-OB
2020-03-19
Myo Plus trial kit - 642V64=T-PLUS-S
2020-03-19
Myo Cuff - 757M20=50
2020-03-19
Myo Cuff - 757M20=50-OB
2020-03-19
Myo Cuff - 757M20=50-S
2020-03-19