The following data is part of a premarket notification filed by Medi-man Rehabilitation Products, Inc. with the FDA for Malibu Bathing System.
| Device ID | K925195 |
| 510k Number | K925195 |
| Device Name: | MALIBU BATHING SYSTEM |
| Classification | Bath, Hydro-massage |
| Applicant | MEDI-MAN REHABILITATION PRODUCTS, INC. 5630 TOMKEN ROAD MISSISSAUGA, ONTARIO, Canada, L4w 1p4, CA |
| Contact | Jane Belrose |
| Correspondent | Jane Belrose MEDI-MAN REHABILITATION PRODUCTS, INC. 5630 TOMKEN ROAD MISSISSAUGA, ONTARIO, Canada, L4w 1p4, CA |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-15 |
| Decision Date | 1994-10-17 |