The following data is part of a premarket notification filed by Recovr,inc with the FDA for Recovr Rehabilitation System.
Device ID | K151446 |
510k Number | K151446 |
Device Name: | Recovr Rehabilitation System |
Classification | Interactive Rehabilitation Exercise Devices |
Applicant | Recovr,Inc Post Office Box 772 Clemson, SC 29633 |
Contact | Austen Hayes |
Correspondent | Kathryn Cole Translational Science Solutions LLC 92 Hasell Street, Suite 401 Charleston, SC 29401 |
Product Code | LXJ |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-29 |
Decision Date | 2015-09-18 |
Summary: | summary |