MODEL 938 BATHING SYSTEM
FDA 510(k) clearance K880355 · decided 1988-02-16
Clearance details
- K-number
- K880355
- Device name
- MODEL 938 BATHING SYSTEM
- Applicant
- Ferno Ille-Forge
- Decision
- Substantially Equivalent
- Date received
- 1988-01-26
- Decision date
- 1988-02-16
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- ILJ
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Williamsport, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PARKER 500 (K110994) | Arjohuntleigh, Inc. | 2011-07-06 |
| IMMERSION HYDROBATH (K082951) | Arjo Hospital Equipment AB | 2009-04-08 |
| MBATH 1000 (60) (K052479) | Enneking Medical, Inc. | 2006-01-26 |
| PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (K040772) | Penner Manufacturing, Inc. | 2004-04-05 |
| SUPERIOR BATH, MODEL 6300 (K012061) | Penner Manufacturing, Inc. | 2001-07-19 |
| CASCADE BATH, MODEL 6900 (K012057) | Penner Manufacturing, Inc. | 2001-07-19 |
| RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (K001079) | Arjo, Inc. | 2000-05-01 |
| VANNA BATHING SYSTEM (K993872) | Vancare, Inc. | 2000-02-16 |
| A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (K992779) | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 |
| HYDROTONE-THERMAL CAPSULE SYSTEM (K991184) | Nats Corp. | 1999-06-23 |
| VICHY SHOWER (K980909) | Bouvier Hydro, Inc. | 1998-08-11 |
| EQUINOXE (K980920) | Bouvier Hydro, Inc. | 1998-07-16 |
Recalls involving this device
No recalls on record reference this clearance.