Cleared Traditional

CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR

K951414 · Champion Mfg. Corp. · Physical Medicine

Aug 1995

Decision

137d

Days

Class 1

Risk

About This 510(k) Submission

K951414 is an FDA 510(k) clearance for the CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Champion Mfg. Corp. (Shipshewana, US). The FDA issued a Cleared decision on August 11, 1995, 137 days after receiving the submission on March 27, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number	K951414 FDA.gov
FDA Decision	Cleared SN
Date Received	March 27, 1995
Decision Date	August 11, 1995
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—