The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Kinetic 8080 Hand & Wrist Contin. Passive Machine.
| Device ID | K850332 |
| 510k Number | K850332 |
| Device Name: | KINETIC 8080 HAND & WRIST CONTIN. PASSIVE 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 | 1985-01-28 |
| Decision Date | 1985-05-01 |