ISA · Massager, Therapeutic, Electric
Physical Medicine · 21 CFR 890.5660 · Class 1
Overview
| Product Code | ISA |
|---|---|
| Device Name | Massager, Therapeutic, Electric |
| 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 (20 of 100)
Showing 20 most recent of 100 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | Feb 6, 2025 | SESE |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | Jun 5, 2024 | SESE |
| K221865 | BTL-094 | BTL Industries, Inc. | Apr 14, 2023 | SESE |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | Jan 27, 2023 | SESE |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | Oct 12, 2022 | SESE |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | Jul 11, 2022 | SESE |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | May 5, 2021 | SESE |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | Dec 21, 2018 | SESE |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | Apr 13, 2018 | SESE |
| K053225 | CELLU M6 KEYMODULE I | Lpg One, Inc. | Nov 6, 2006 | SESE |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | Jan 22, 2004 | SESE |
| K002908 | JET THERAPY | Jet Therapy | Aug 30, 2001 | SESE |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | Jan 18, 2000 | SESE |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | Sep 29, 1995 | SN |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | Aug 14, 1995 | SESE |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | Aug 2, 1995 | SESE |
| K950931 | AVON MASSAGING HAIRBRUSH | Siegel,Mandell & Davidson,P.C. | Apr 5, 1995 | SN |
| K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Ultrassage, Inc. | Mar 7, 1995 | SN |
| K950322 | RELAXY-THE WONDER HAND | Kinsei Shiatsu, Inc. | Feb 14, 1995 | SN |
| K950321 | SHAPE UP MOMI ROLLER | Kinsei Shiatsu, Inc. | Feb 14, 1995 | SN |
Top Applicants
- Conair Corp. — 10 clearances
- General Physiotherapy, Inc. — 5 clearances
- Kinsei Shiatsu, Inc. — 5 clearances
- Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. — 3 clearances
- Omron Healthcare, Inc. — 3 clearances
