Medical Device Manufacturer · US , Walker , MI

Empi - FDA 510(k) Cleared Devices

60 submissions · 56 cleared · Since 1977

Recent clearances: EMPI CONTINUUM, EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR, HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM

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60

Total

56

Cleared

0

Denied

FDA 510(k) Regulatory Record - Empi Neurology ✕

29 devices

1-12 of 29

Cleared Jun 05, 2009

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

Neurology · 65d

Cleared Jan 22, 2007

SELECT TENS, MODEL 4600S

Neurology · 223d

Cleared Dec 17, 2004

INFINITY ELECTROTHERAPY SYSTEM

Neurology · 140d

Cleared Apr 14, 1997

Neurology · 83d

Cleared May 17, 1996

FOCUS MODEL 795 UNIT

Neurology · 387d

Cleared Mar 20, 1996

EPIX XL TENS UNIT

Neurology · 331d

Cleared Jun 08, 1990

TBD TENS REUSABLE ELECTRODE

Neurology · 23d

Cleared Mar 23, 1990

MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE

Neurology · 16d

Cleared Mar 23, 1990

MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE

Neurology · 16d

Cleared Dec 21, 1989

MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN

Neurology · 38d

Cleared Jun 01, 1989

EMPI, MODEL 489, TENS

Neurology · 115d

Cleared Mar 16, 1989

EMPI ISLAND TENS ELECTRODE

Neurology · 38d