ISA · Class I · 21 CFR 890.5660

FDA Product Code ISA: Massager, Therapeutic, Electric

Electric massagers provide accessible pain relief and muscle relaxation. FDA product code ISA covers therapeutic electric massagers cleared as medical devices.

These devices use vibration or percussive motion to stimulate soft tissue, improve circulation, and reduce muscle tension for the relief of minor muscular aches and pains. They are available in handheld and stationary configurations for self-use.

ISA devices are Class I medical devices, regulated under 21 CFR 890.5660 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include Omron Healthcare, Inc., Cynosure, Inc. and Storz Medical AG.

100
Total
100
Cleared
137d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 86d recently vs 138d historically

FDA 510(k) Cleared Massager, Therapeutic, Electric Devices (Product Code ISA)

100 devices
1–24 of 100
Cleared Feb 06, 2025
VMAT PRO
K243488
Termosalud
Physical Medicine · 86d
Cleared Jun 05, 2024
ShockPhysio Mobile (model SW3200 Basic)
K240358
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 120d
Cleared Apr 14, 2023
BTL-094
K221865
BTL Industries, Inc.
Physical Medicine · 291d
Cleared Jan 27, 2023
Omnispec ED1000
K210166
Medispec, Ltd.
Physical Medicine · 736d
Cleared Oct 12, 2022
OW100S (model OW100S-US)
K213120
Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
Physical Medicine · 380d
Cleared Jul 11, 2022
DolorClast Radial
K220538
E.M.S Electro Medical Systems S.A
Physical Medicine · 136d
Cleared May 05, 2021
OrthoGold 100
K210451
Tissue Regeneration Technologies, LLC
Physical Medicine · 78d
Cleared Dec 21, 2018
OrthoGold 100
K182682
Tissue Regeneration Technologies
Physical Medicine · 86d
Cleared Apr 13, 2018
D-Actor 200 Vibration Massage System
K173692
Storz Medical AG
Physical Medicine · 133d
Cleared Jan 22, 2004
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
K030876
Cynosure, Inc.
Physical Medicine · 308d
Cleared Mar 04, 1994
OMRON MASSAGER MODEL HM-45
K935459
Omron Healthcare, Inc.
Physical Medicine · 112d
Cleared Mar 04, 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462
Omron Healthcare, Inc.
Physical Medicine · 112d
Cleared Mar 04, 1994
OMRON MASSAGER MODEL HM-102
K935581
Omron Healthcare, Inc.
Physical Medicine · 106d
Cleared Oct 14, 1983
SENSORY ROLLER MASSAGER
K833090
Maddak, Inc.
Physical Medicine · 32d
Cleared Mar 04, 1981
MAGIC CUSHION MASSAGER
K810447
Fred Sammons, Inc.
Physical Medicine · 13d

About Product Code ISA - Regulatory Context

510(k) Submission Activity

100 total 510(k) submissions under product code ISA since 1977, with 100 receiving FDA clearance (average review time: 137 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - ISA Product Code

Recent submissions under ISA have taken an average of 86 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.

ISA devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →