Cottrell 90/90 Backtrac
FDA 510(k) K802555 · Lossing Orthopedic, Inc.
510(k) numberK802555
Submission
- Device name
- Cottrell 90/90 Backtrac
- Applicant
- Lossing Orthopedic, Inc.
Mchenry, IL, US - Received
- October 16, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HST – Apparatus, Traction, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5850
- Specialty
- Orthopedic
Other 510(k)s with product code HST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…HST · Traditional | Stl International, Inc. | 12/30/2016SE |
| K110858 | Lo-Bak TraxHST · Traditional | Roland F Berthiaume, DC | 08/02/2011SE |
| K984190 | Back-On-Trac, Model 101BOTHST · Traditional | Back-On-Track, Inc. | 03/15/1999SE |
| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
| K870212 | Arthroscopic Shoulder HolderHST · Traditional | Dyonics, Inc. | 02/20/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
More from Comfortex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900475 | Distrac(Tm) TableITH · Traditional | 05/24/1990SE |
| 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 |
Questions and answers
When was Cottrell 90/90 Backtrac cleared by the FDA?
Cottrell 90/90 Backtrac (K802555) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 15 days after the submission was received.
What is the product code of K802555?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.