ISAClass I

Massager, Therapeutic, Electric

21 CFR 890.5660 / Physical Medicine

ISA is the FDA product code for Massager, Therapeutic, Electric, a class I device type, regulated under 21 CFR 890.5660. As of 2026-09-10, FDA records hold 100 510(k) clearances under this code, the most recent dated 2025-02-06, and 10 recalls.

Classification record

Product code: ISA
Device name: Massager, Therapeutic, Electric
Regulation: 21 CFR 890.5660
Device class: Class I
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 100
Ingested recalls: 10

Clearances, product code ISA

By decision year

100 clearances under product code ISA with a decision year between 1977 and 2025, 1994 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code ISA by decision year
Year	Clearances
1977	1
1978	1
1980	1
1981	4
1982	1
1983	6
1984	2
1985	4
1986	6
1987	3
1988	4
1989	6
1990	5
1991	3
1992	3
1993	6
1994	19
1995	12
2000	1
2001	1
2004	1
2006	1
2018	2
2021	1
2022	2
2023	2
2024	1
2025	1

Applicants with the most clearances

Product code ISA

Applicants holding the most 510(k) clearances under product code ISA
Applicant	Clearances
Conair LLC.	10
General Physiotherapy, Inc.	5
Kinsei Shiatsu, Inc.	5
Nexus Co., Ltd. C/O Yama Trans Co., Ltd.	3
Omron Healthcare Co., Ltd.	3
Wahl Clipper Corp	3
Kolvin Industries, Ltd.	2
Tissue Regeneration Technologies	2
Westminster International Co., Inc.	2
Windmere Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 783 companies shown, in name order