Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3490](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3490) → IQF — Orthosis, Cervical-Thoracic, Rigid

# IQF · Orthosis, Cervical-Thoracic, Rigid

_Physical Medicine · 21 CFR 890.3490 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF

## Overview

- **Product Code:** IQF
- **Device Name:** Orthosis, Cervical-Thoracic, Rigid
- **Regulation:** [21 CFR 890.3490](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3490)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **GMP exempt:** yes

## Identification

A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

## 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 § 890.9. 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832741](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K832741.md) | JASON CERVICAL ORTHOSIS | Orthomedics | Sep 20, 1983 | SESE |
| [K812342](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K812342.md) | ZEE EXTRICATION DEVICE | Zee Medical Products Co., Inc. | Sep 21, 1981 | SESE |
| [K811297](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K811297.md) | CERVICAL SUPPORT | Orthomedics | May 27, 1981 | SESE |
| [K810555](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K810555.md) | SCOLIOSIS ORTHOTIC SYSTEM | Orthomedics | Mar 13, 1981 | SESE |
| [K791350](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K791350.md) | POPE AMBULATORY HALO VEST | Hospital Products Co. | Aug 3, 1979 | SESE |
| [K781761](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K781761.md) | KENDRICK EXTRICATION DEVICE | Medi-Ked, Inc. | Oct 27, 1978 | SESE |
| [K780489](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF/K780489.md) | SPINE BOARD | Marullo, Baldwin, Frieden, Gatewood, | Apr 12, 1978 | SESE |

## Top Applicants

- Orthomedics — 3 clearances
- Hospital Products Co. — 1 clearance
- Marullo, Baldwin, Frieden, Gatewood, — 1 clearance
- Medi-Ked, Inc. — 1 clearance
- Zee Medical Products Co., Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQF)

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