Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5160](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5160) → KMO — Binder, Elastic

# KMO · Binder, Elastic

_General Hospital · 21 CFR 880.5160 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO

## Overview

- **Product Code:** KMO
- **Device Name:** Binder, Elastic
- **Regulation:** [21 CFR 880.5160](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5160)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)
- **GMP exempt:** yes

## Identification

A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

## 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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921852](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO/K921852.md) | 4 SURE TM RECTAL TUBE | Boston Pacific Medical, Inc. | Oct 8, 1993 | SESE |
| [K893809](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO/K893809.md) | COUGH PILLOW | Custom Hospitals Products | Aug 28, 1989 | SESE |
| [K883214](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO/K883214.md) | THORACIC SUPPORT SYSTEM | Storer Medical Products | Jan 17, 1989 | SESE |
| [K882592](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO/K882592.md) | HEART HUGGER STERNUM SUPPORT HARNESS | General Cardiac Technology, Inc. | Sep 20, 1988 | SESE |
| [K792629](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO/K792629.md) | STERILIZATION PROCESS/T-BINDER | Procter & Gamble Mfg. Co. | Jan 11, 1980 | SESE |

## Top Applicants

- Boston Pacific Medical, Inc. — 1 clearance
- Custom Hospitals Products — 1 clearance
- General Cardiac Technology, Inc. — 1 clearance
- Procter & Gamble Mfg. Co. — 1 clearance
- Storer Medical Products — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMO)

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