Product code KTC
- Device name
- Bath, Sitz, Nonpowered
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5125
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912179 | THE SPRITZ BATH | The Spritz Co. | 1991-08-28 |
| K890085 | SIT-N-BATHE SITZ BATH | Drummond Industries, Inc. | 1989-02-13 |
| K862600 | SITZ BATH | W. C. Green, D.D.S. | 1986-07-18 |
| K851309 | ABCO PLASTIC UTENSILS | Abco Dealers, Inc. | 1985-07-01 |
| K841711 | MAC LEE SITZ BATH | Mac Lee Medical Products | 1984-05-07 |
| K831762 | SITZ BATH, SINGLE PATIENT USE #8100 | Lsl Industries, Inc. | 1983-06-24 |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | 1980-05-02 |
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|---|---|---|---|
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| 00661392012547 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-16 |
| 07392532279416 | DS PrimeTaper | Dentsply Implants Manufacturing GmbH | 2024-06-03 |
| 07392532279409 | DS PrimeTaper | Dentsply Implants Manufacturing GmbH | 2024-06-03 |
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