The following data is part of a premarket notification filed by Universal Gym Equipment, Inc. with the FDA for Musculoskeletal Evaluation Rehabilitation/conditio.
Device ID | K873659 |
510k Number | K873659 |
Device Name: | MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | UNIVERSAL GYM EQUIPMENT, INC. C/O DARBY & DARBY 405 LEXINGTON AVENUE New York, NY 10174 |
Contact | Gordon D Coplein |
Correspondent | Gordon D Coplein UNIVERSAL GYM EQUIPMENT, INC. C/O DARBY & DARBY 405 LEXINGTON AVENUE New York, NY 10174 |
Product Code | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-10 |
Decision Date | 1988-04-21 |