Medical Device Manufacturer · US , Commerce Township , MI

Homedics, Inc.

2 submissions · 2 cleared · Since 2000

Total

Cleared

Denied

Homedics, Inc. — FDA 510(k) Submissions

Homedics, Inc. has submitted 2 FDA 510(k) premarket notifications since 2000, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Toothbrush, Powered, Bath, Paraffin . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

SONICWAVE SONIC PLAQUE REMOVER

K012914 · JEQ Toothbrush, Powered · Dental

Oct 2001 32d

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

K001860 · IMC Bath, Paraffin · Physical Medicine

Aug 2000 52d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Homedics, Inc.

Homedics, Inc. — FDA 510(k) Submissions

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