Distrac(Tm) Table
FDA 510(k) K900475 · Lossing Orthopedic, Inc.
510(k) numberK900475
Submission
- Device name
- Distrac(Tm) Table
- Applicant
- Lossing Orthopedic, Inc.
Minneapolis, MN, US - Received
- February 1, 1990
- Decision date
- May 24, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITH – Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Specialty
- Physical Medicine
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More from Integra Life Sciences
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|---|---|---|
| K864152 | Back Saver Lift Belt/Wheelchair Transfer DeviceILK · Traditional | 02/05/1987SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | 08/07/1986SE |
| K843581 | Prom NaidITH · Traditional | 12/11/1984SE |
| K840551 | MobilizerION · Traditional | 03/23/1984SE |
| K823236 | Back on Track Inversion Therapy & ExerION · Traditional | 01/21/1983SE |
| K813017 | NecktracHST · Traditional | 11/25/1981SE |
| K802555 | Cottrell 90/90 BacktracHST · Traditional | 10/31/1980SE |
Questions and answers
When was Distrac(Tm) Table cleared by the FDA?
Distrac(Tm) Table (K900475) received a 510(k) decision of Substantially Equivalent on May 24, 1990, 112 days after the submission was received.
What is the product code of K900475?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.