The following data is part of a premarket notification filed by Medmetric Corp. with the FDA for Flexercycle.
Device ID | K904823 |
510k Number | K904823 |
Device Name: | FLEXERCYCLE |
Classification | Exerciser, Measuring |
Applicant | MEDMETRIC CORP. 7542 TRADE ST. San Diego, CA 92121 -2412 |
Contact | R Watkins |
Correspondent | R Watkins MEDMETRIC CORP. 7542 TRADE ST. San Diego, CA 92121 -2412 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-25 |
Decision Date | 1991-01-30 |