510(k) K974321
- Device
- HYDROTONE
- Applicant
- NORTH AMERICAN TECHNICAL SERVICES CORP.
- 510(k) number
- K974321
- Product code
- ILJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-22
- Date received
- 1997-11-17
- Regulation
- 890.5100
- Classification name
- Bath, Hydro-massage
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD C LANZILLOTTO
- Address
- 30 Northport Rd. Sound Beach NY US 11789 11789
FDA Registration Numbers#
- 3026182452
- 1922538
- 3016446653
- 3015139841
- 3007420694
- 3010010434
- 3042227943
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110994 | PARKER 500 | Arjohuntleigh, Inc. | 2011-07-06 |
| K082951 | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | 2009-04-08 |
| K052479 | MBATH 1000 (60) | Enneking Medical, Inc. | 2006-01-26 |
| K040772 | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | Penner Manufacturing, Inc. | 2004-04-05 |
| K012057 | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | 2001-07-19 |
| K012061 | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | 2001-07-19 |
| K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | 2000-05-01 |
| K993872 | VANNA BATHING SYSTEM | Vancare, Inc. | 2000-02-16 |
| K992779 | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | 1999-06-23 |
| K980909 | VICHY SHOWER | Bouvier Hydro, Inc. | 1998-08-11 |
| K980920 | EQUINOXE | Bouvier Hydro, Inc. | 1998-07-16 |
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | 1998-04-21 |
| K980769 | WINDMERE MODEL DS-2 FOOT BATH | Windmere Corp. | 1998-03-27 |
| K971593 | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT | The Silcraft Corp. | 1998-02-26 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases