Cleared Traditional

K800250 - HMB-200
(FDA 510(k) Clearance)

K800250 · Associated Mills, Inc. · Physical Medicine

Mar 1980

Decision

48d

Days

Class 1

Risk

K800250 is an FDA 510(k) clearance for the HMB-200, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Associated Mills, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980, 48 days after receiving the submission on February 6, 1980. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number	K800250 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 1980
Decision Date	March 25, 1980
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—