The following data is part of a premarket notification filed by Enneking Medical Inc. with the FDA for Mbath 1000 (60).
| Device ID | K052479 |
| 510k Number | K052479 |
| Device Name: | MBATH 1000 (60) |
| Classification | Bath, Hydro-massage |
| Applicant | ENNEKING MEDICAL INC. 1801 GUINOTTE AVE. Kansas City, MO 64120 |
| Contact | Stephen Whittenburg |
| Correspondent | Stephen Whittenburg ENNEKING MEDICAL INC. 1801 GUINOTTE AVE. Kansas City, MO 64120 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-09 |
| Decision Date | 2006-01-26 |
| Summary: | summary |