HLE-1000 High/Low Treatment Table
FDA 510(k) K883659 · Rich-Mar Corp.
510(k) numberK883659
Submission
- Device name
- HLE-1000 High/Low Treatment Table
- Applicant
- Rich-Mar Corp.
Inola, OK, US - Received
- August 26, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- INQ – Table, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3760
- Specialty
- Physical Medicine
Other 510(k)s with product code INQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960336 | Cardon Physical Therapy Table Model R27645INQ · Traditional | Cardon Rehabilitation Products, Inc. | 02/13/1996SE |
| K960334 | Cardon Physical Therapy Table Model R27116INQ · Traditional | Cardon Rehabilitation Products, Inc. | 02/13/1996SE |
| K960332 | Cardon Physical Therapy Table Model R28598INQ · Traditional | Cardon Rehabilitation Products, Inc. | 02/13/1996SE |
| K960196 | Tri W-G, Inc Table, Tilt/Exam/Treatment Model 777INQ · Traditional | Tri W-G, Inc. | 02/07/1996SE |
| K953621 | EVT-3300INQ · Traditional | U.S. Table, Inc. | 11/14/1995SE |
| K953622 | PTT 6200 Elevation Therapy TableINQ · Traditional | U.S. Table, Inc. | 09/11/1995SE |
| K952357 | The Hill Adjustable Podiatry ModelINQ · Traditional | Hill Laboratories Co. | 07/06/1995SE |
| K951419 | Flex D-4000INQ · Traditional | U.S. Table, Inc. | 06/30/1995SE |
| K952600 | EVT-5000BXINQ · Traditional | U.S. Table, Inc. | 06/22/1995SE |
| K952359 | The Hill Adjustable HA90CINQ · Traditional | Hill Laboratories Co. | 06/22/1995SE |
More from Hill Laboratories Co.
| 510(k) | Device | Decision |
|---|---|---|
| K040679 | Rich-Mar Autoprism Infrared LampILY · Traditional | 05/07/2004SE |
| K031018 | Autogel PadMUI · Traditional | 12/08/2003SE |
| K032941 | Autosound 7.6 Muscle Stimulator, TENS, Therapeutic Ultrasound and Combination DeviceIPF · Special | 10/22/2003SE |
| K021483 | Rich-Mar Therasound 6.5 Therapeutic UltrasoundIMI · Traditional | 09/13/2002SE |
| K013771 | Modification to: Winner CM-2 Muscle Stimulator, TENS, Therapeutic Ultrasound and…IPF · Special | 01/18/2002SE |
| K013770 | Modification to: Winner ST-2 StimulatorIPF · Special | 01/18/2002SE |
| K012848 | Winner CM4 Combination UnitGZJ · Traditional | 10/25/2001SE |
| K000808 | Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS DeviceIPF · Traditional | 08/25/2000SE |
| K982544 | Rich-Mar US500, US750, US1000 Therapeutic Unltrasound DevicesIMI · Traditional | 11/19/1998SE |
| K952089 | Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound…LIH · Traditional | 08/11/1995SN |
Questions and answers
When was HLE-1000 High/Low Treatment Table cleared by the FDA?
HLE-1000 High/Low Treatment Table (K883659) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 48 days after the submission was received.
What is the product code of K883659?
The FDA product code is INQ – Table, Powered, a Class I (low risk) device regulated under 21 CFR 890.3760.