The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Orthoderm Therapy Bed.
Device ID | K874801 |
510k Number | K874801 |
Device Name: | ORTHODERM THERAPY BED |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | HEALTH PRODUCTS, INC. 15401 VANTAGE PARKWAY WEST #114 Houston, TX 77032 |
Contact | Jack H Hess |
Correspondent | Jack H Hess HEALTH PRODUCTS, INC. 15401 VANTAGE PARKWAY WEST #114 Houston, TX 77032 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-23 |
Decision Date | 1988-02-05 |