The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Shower Chairs.
| Device ID | K922045 |
| 510k Number | K922045 |
| Device Name: | SHOWER CHAIRS |
| Classification | Chair, With Casters |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Kotula Cook |
| Correspondent | Kotula Cook MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | INM |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1992-05-26 |