The following data is part of a premarket notification filed by Rifton Equipment For The Handicapped with the FDA for Rifton Mobile Prone Standers.
Device ID | K921894 |
510k Number | K921894 |
Device Name: | RIFTON MOBILE PRONE STANDERS |
Classification | Wheelchair, Standup |
Applicant | RIFTON EQUIPMENT FOR THE HANDICAPPED 55 NORTHERN BLVD. SUIT 301 Great Neck, NY 11021 |
Contact | Carolann Kotula-cook |
Correspondent | Carolann Kotula-cook RIFTON EQUIPMENT FOR THE HANDICAPPED 55 NORTHERN BLVD. SUIT 301 Great Neck, NY 11021 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-22 |
Decision Date | 1992-05-26 |