LYG · Massager, Therapeutic, Manual
Physical Medicine · 21 CFR 890.5660 · Class 1
Overview
| Product Code | LYG |
|---|---|
| Device Name | Massager, Therapeutic, Manual |
| Regulation | 21 CFR 890.5660 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
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 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Shippert Medical Technologies Corp. | Nov 26, 1996 | SESE |
| K936312 | MANUAL MASSAGE ROLLER | Mckenna & Cuneo | Jan 29, 1996 | SN |
| K952043 | BACK MASSAGER | Eight Corners, Inc. | Sep 1, 1995 | SESE |
| K930613 | HOOKING SYSTEM | Alain Machtelinckx | Jul 12, 1994 | SESE |
| K936148 | STRESS HANDLER | Arocep Enterprises , Ltd. | Apr 21, 1994 | SN |
| K924315 | THE MASSAGER | Four Directions | Oct 8, 1993 | SESE |
| K922366 | SPINE LINE | Dambrecine, Inc. | Jul 13, 1992 | SESE |
| K915361 | THE BODY BUGGY | Innova Corp. | Dec 20, 1991 | SESE |
| K912512 | TAICHI STICK MASSAGER | Focus International, Inc. | Sep 6, 1991 | SESE |
| K903820 | THERA-CANE | Pro Message Co. | Sep 19, 1990 | SESE |
| K884907 | BUMPY MEDICAL MASSAGE MAT | Medical Flotation Systems, Inc. | Dec 27, 1988 | SESE |
| K881081 | DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER | Ferguson Medical | Jul 21, 1988 | SESE |
| K881080 | 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
