The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for First Mpj Continuous Passive Motion Device.
| Device ID | K926262 |
| 510k Number | K926262 |
| Device Name: | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE |
| Classification | Exerciser, Powered |
| Applicant | SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Contact | Thomas E Sgarlato |
| Correspondent | Thomas E Sgarlato SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-18 |
| Decision Date | 1994-01-26 |