HST — Apparatus, Traction, Non-Powered Class I
FDA product code HST covers "Apparatus, Traction, Non-Powered", a Class I medical device regulated under 21 CFR 888.5850. Submissions are reviewed by the Orthopedic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HST
- Device Class
- Class I
- Regulation Number
- 888.5850
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162702 | stl international | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Dec | December 30, 2016 |
| K110858 | roland f berthiaume, dc | LO-BAK TRAX | August 2, 2011 |
| K984190 | back-on-track | BACK-ON-TRAC, MODEL 101BOT | March 15, 1999 |
| K872121 | joseph a. kott, m.d | K AND D HOME TRACT | August 12, 1987 |
| K870212 | dyonics | ARTHROSCOPIC SHOULDER HOLDER | February 20, 1987 |
| K870125 | orthopedic systems | EXTREMITY ELEVATOR | February 4, 1987 |
| K870102 | orthopedic systems | TUPPER TROLLEY | February 3, 1987 |
| K864765 | ferno-washington | MODEL 668, TRACTION SPLINT, ADULT | December 17, 1986 |
| K862874 | lossing orthopedic | THE TOWERED 90/90 UNIT | August 7, 1986 |
| K860037 | comfortex | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | January 21, 1986 |
| K855179 | comfortex | TRANSFER-TRAX (TM) SPLINT TRACTION | January 21, 1986 |
| K844239 | vencor | NEC-KRADLE BY VENCOR | November 19, 1984 |
| K841388 | acufex microsurgical | ACUFEX SHOULDER HOLDER | May 16, 1984 |
| K841368 | orthopedic systems | HYPERBARIC OXYGEN GURNEY- | May 16, 1984 |
| K831888 | portable travtion device | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG | July 12, 1983 |
| K830244 | warm and form, orthopedic materials | TRACTION ACCESSORIES | March 9, 1983 |
| K823813 | danek medical | TRACTION ACCESSORIES | January 14, 1983 |
| K823395 | orthopedic systems | TRACTION-STEEL FRAMING SYSTEM | December 3, 1982 |
| K823372 | orthopedic systems | OCTAGONAL ALUMINUM FRAMING SYSTEM | December 3, 1982 |
| K823392 | orthopedic systems | FOREARM REDUCTION UNIT | November 29, 1982 |