Product code FRK— General Hospital

FDA has cleared 4 devices under product code FRK between 1979 and 1989, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19891 clearance
• 19793 clearances

• Fem-Gard, Inc.2 clearances
• Jedmed Instrument Co.1 clearance
• American Health Care Industries, Inc.1 clearance

• K896275 — JEDMED J-II CHAIRJedmed Instrument Co.·1989-12-18
• K791016 — ULTICARE 2500 TREATMENT CHAIRAmerican Health Care Industries, Inc.·1979-06-27
• K790954 — HEEL GARDFem-Gard, Inc.·1979-06-20
• K790955 — COVER GARDFem-Gard, Inc.·1979-06-20