HST · Apparatus, Traction, Non-Powered
Orthopedic · 21 CFR 888.5850 · Class 1
Overview
| Product Code | HST |
|---|---|
| Device Name | Apparatus, Traction, Non-Powered |
| Regulation | 21 CFR 888.5850 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
| GMP Exempt | Yes |
Identification
A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table | Stl International, Inc. | Dec 30, 2016 | SESE |
| K110858 | LO-BAK TRAX | Roland F Berthiaume, DC | Aug 2, 2011 | SESE |
| K984190 | BACK-ON-TRAC, MODEL 101BOT | Back-On-Track, Inc. | Mar 15, 1999 | SESE |
| K872121 | K AND D HOME TRACT | Joseph A. Kott, M.D. | Aug 12, 1987 | SESE |
| K870212 | ARTHROSCOPIC SHOULDER HOLDER | Dyonics, Inc. | Feb 20, 1987 | SESE |
| K870125 | EXTREMITY ELEVATOR | Orthopedic Systems, Inc. | Feb 4, 1987 | SESE |
| K870102 | TUPPER TROLLEY | Orthopedic Systems, Inc. | Feb 3, 1987 | SESE |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | Ferno-Washington, Inc. | Dec 17, 1986 | SESE |
| K862874 | THE TOWERED 90/90 UNIT | Lossing Orthopedic, Inc. | Aug 7, 1986 | SESE |
| K860037 | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | Comfortex, Inc. | Jan 21, 1986 | SESE |
| K855179 | TRANSFER-TRAX (TM) SPLINT TRACTION | Comfortex, Inc. | Jan 21, 1986 | SESE |
| K844239 | NEC-KRADLE BY VENCOR | Vencor | Nov 19, 1984 | SESE |
| K841388 | ACUFEX SHOULDER HOLDER | Acufex Microsurgical, Inc. | May 16, 1984 | SESE |
| K841368 | HYPERBARIC OXYGEN GURNEY- | Orthopedic Systems, Inc. | May 16, 1984 | SESE |
| K831888 | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG | Portable Travtion Device Co. | Jul 12, 1983 | SESE |
| K830244 | TRACTION ACCESSORIES | Warm & Form, Orthopedic Materials | Mar 9, 1983 | SESE |
| K823813 | TRACTION ACCESSORIES | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823395 | TRACTION-STEEL FRAMING SYSTEM | Orthopedic Systems, Inc. | Dec 3, 1982 | SESE |
| K823372 | OCTAGONAL ALUMINUM FRAMING SYSTEM | Orthopedic Systems, Inc. | Dec 3, 1982 | SESE |
| K823392 | FOREARM REDUCTION UNIT | Orthopedic Systems, Inc. | Nov 29, 1982 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 8 clearances
- Lossing Orthopedic, Inc. — 3 clearances
- Comfortex, Inc. — 2 clearances
- Biomet, Inc. — 2 clearances
- Zee Medical Products Co., Inc. — 1 clearance
