LIH · Class II · 21 CFR 882.5890

FDA Product Code LIH: Interferential Current Therapy

Leading manufacturers include Excel Tech. , Ltd., Biomedical Life Systems, Inc. and Henley Intl..

Total

Cleared

193d

Avg days

1983

Since

Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Interferential Current Therapy Devices (Product Code LIH)

73 devices

1–24 of 73

Vision Quest Industries Inc./Dba VQ Orthocare

Neurology · 163d

Cleared Dec 17, 2004

INFINITY ELECTROTHERAPY SYSTEM

INTERFERENTIAL STIMULATOR, MODEL BMLS02-6

K040007

Biomedical Life Systems, Inc.

Neurology · 187d

Cleared Apr 29, 2004

INTERFERENTIAL STIMULATOR, MODEL BMLS03-6

K040824

Biomedical Life Systems, Inc.

Neurology · 30d

Cleared Mar 22, 1996

ISOTRON III, ISOTRON IV

RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE

INTERFERENTIAL STIMULATOR MODEL IMF4150/A

K925687

Biomedical Life Systems, Inc.

Chattanooga Group, Inc.

INTERFERENTIAL STIMULATOR MODEL INF 4150/A

K921441

Biomedical Life Systems, Inc.

Neurology · 44d

Cleared May 08, 1991

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A

K905571

Biomedical Life Systems, Inc.

Neurology · 147d

Cleared May 24, 1989

IF-II (TM), MODEL 9800

K883462

Medical Devices, Inc.

About Product Code LIH - Regulatory Context

510(k) Submission Activity

73 total 510(k) submissions under product code LIH since 1983, with 73 receiving FDA clearance (average review time: 193 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

FDA Product Code LIH: Interferential Current Therapy

FDA 510(k) Cleared Interferential Current Therapy Devices (Product Code LIH)

About Product Code LIH - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights