The following data is part of a premarket notification filed by Healthtech Industries, Inc. with the FDA for Tips And Pads, Cane,crutch And Walker.
Device ID | K854940 |
510k Number | K854940 |
Device Name: | TIPS AND PADS, CANE,CRUTCH AND WALKER |
Classification | Bed, Manual |
Applicant | HEALTHTECH INDUSTRIES, INC. 3121 GARDENBROOK DR. Farmers Branch, TX 75234 |
Contact | Carla Beller |
Correspondent | Carla Beller HEALTHTECH INDUSTRIES, INC. 3121 GARDENBROOK DR. Farmers Branch, TX 75234 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-10 |
Decision Date | 1986-01-30 |