Cleared Traditional

K800007 - WORK SIMULATOR
(FDA 510(k) Clearance)

K800007 · Baltimore Therapeutic Equipment Co. · Physical Medicine device

Jan 1980

Decision

18d

Days

Class 1

Risk

K800007 is an FDA 510(k) clearance for the WORK SIMULATOR. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).

Submitted by Baltimore Therapeutic Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980, 18 days after receiving the submission on January 3, 1980.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K800007 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 03, 1980
Decision Date	January 21, 1980
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—