The following data is part of a premarket notification filed by Joerns Healthcare, Inc. with the FDA for Bath Air Spa Fixed Height Hydraulic Operated/adjustable Height Hydraulic/fixed Height Electric Reclining/height Electric.
| Device ID | K964926 |
| 510k Number | K964926 |
| Device Name: | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC |
| Classification | Bath, Hydro-massage |
| Applicant | JOERNS HEALTHCARE, INC. 5001 JOERNS DR. Stevens Point, WI 54481 -5040 |
| Contact | Dean Sommerfeld |
| Correspondent | Dean Sommerfeld JOERNS HEALTHCARE, INC. 5001 JOERNS DR. Stevens Point, WI 54481 -5040 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-11-03 |
| Summary: | summary |