Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
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- Devices
- 1
What Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. makes
Combi Co. Ltd. manufactures the SYSTEM5RH, a stationary exercise bicycle designed for indoor cycling workouts. The device is intended for use in fitness and rehabilitation settings to provide cardiovascular exercise.
The SYSTEM5RH is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
SYSTEM5RH Stationary Exercise Bicycle Ref K881475
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. have in the registry?
The registry currently lists 1 device for Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.'s devices?
Among its 1 most recently registered device, Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. in the registry?
The most recently registered devices listed for Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. include SYSTEM5RH STATIONARY EXERCISE BICYCLE.