The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Foot Weight Alarm.
| Device ID | K962591 |
| 510k Number | K962591 |
| Device Name: | FOOT WEIGHT ALARM |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE., SUITE 130 Cleveland, OH 44106 |
| Contact | Robert N Schmidt |
| Correspondent | Robert N Schmidt CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE., SUITE 130 Cleveland, OH 44106 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-12-04 |
| Summary: | summary |