The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Hip Continuous Passive Motion Machine.
Device ID | K862314 |
510k Number | K862314 |
Device Name: | HIP CONTINUOUS PASSIVE MOTION MACHINE |
Classification | Exerciser, Powered |
Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-18 |
Decision Date | 1986-07-15 |