Back Specialist
FDA 510(k) K944329 · Health Care Mfg., Inc.
510(k) numberK944329
Submission
- Device name
- Back Specialist
- Applicant
- Health Care Mfg., Inc.
Springfield, MO, US - Received
- September 6, 1994
- Decision date
- March 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K022737 | Hcmi X-Ray High Requency Chiropractic RadiographicKPR · Traditional | 10/22/2002SE |
| K022667 | Hcmi X-RayKPR · Traditional | 10/22/2002SE |
| K952441 | LegendINQ · Traditional | 06/19/1995SE |
| K951323 | VH-2000INQ · Traditional | 06/07/1995SE |
| K951382 | HLT 406INQ · Traditional | 06/01/1995SE |
| K944699 | ATT-300ITH · Traditional | 05/26/1995SE |
Questions and answers
When was Back Specialist cleared by the FDA?
Back Specialist (K944329) received a 510(k) decision of Substantially Equivalent on March 15, 1995, 190 days after the submission was received.
What is the product code of K944329?
The FDA product code is INQ – Table, Powered, a Class I (low risk) device regulated under 21 CFR 890.3760.