The following data is part of a premarket notification filed by Universal Gym Equipment, Inc. with the FDA for Ankle Reflex Treatment Unit (artu).
| Device ID | K873658 |
| 510k Number | K873658 |
| Device Name: | ANKLE REFLEX TREATMENT UNIT (ARTU) |
| Classification | Exerciser, Powered |
| 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 | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1988-04-21 |