Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660) → LYG — Massager, Therapeutic, Manual

# LYG · Massager, Therapeutic, Manual

_Physical Medicine · 21 CFR 890.5660 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG

## Overview

- **Product Code:** LYG
- **Device Name:** Massager, Therapeutic, Manual
- **Regulation:** [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

## 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.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K963704](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K963704.md) | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Shippert Medical Technologies Corp. | Nov 26, 1996 | SESE |
| [K936312](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K936312.md) | MANUAL MASSAGE ROLLER | Mckenna & Cuneo | Jan 29, 1996 | SN |
| [K952043](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K952043.md) | BACK MASSAGER | Eight Corners, Inc. | Sep 1, 1995 | SESE |
| [K930613](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K930613.md) | HOOKING SYSTEM | Alain Machtelinckx | Jul 12, 1994 | SESE |
| [K936148](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K936148.md) | STRESS HANDLER | Arocep Enterprises , Ltd. | Apr 21, 1994 | SN |
| [K924315](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K924315.md) | THE MASSAGER | Four Directions | Oct 8, 1993 | SESE |
| [K922366](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K922366.md) | SPINE LINE | Dambrecine, Inc. | Jul 13, 1992 | SESE |
| [K915361](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K915361.md) | THE BODY BUGGY | Innova Corp. | Dec 20, 1991 | SESE |
| [K912512](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K912512.md) | TAICHI STICK MASSAGER | Focus International, Inc. | Sep 6, 1991 | SESE |
| [K903820](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K903820.md) | THERA-CANE | Pro Message Co. | Sep 19, 1990 | SESE |
| [K884907](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K884907.md) | BUMPY MEDICAL MASSAGE MAT | Medical Flotation Systems, Inc. | Dec 27, 1988 | SESE |
| [K881081](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K881081.md) | DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER | Ferguson Medical | Jul 21, 1988 | SESE |
| [K881080](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LYG/K881080.md) | DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER | Ferguson Medical | Jul 21, 1988 | SESE |

## Top Applicants

- Ferguson Medical — 2 clearances
- Alain Machtelinckx — 1 clearance
- Arocep Enterprises , Ltd. — 1 clearance
- Dambrecine, Inc. — 1 clearance
- Eight Corners, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com