Product code LBE— Physical Medicine

FDA has cleared 8 devices under product code LBE between 1978 and 2023, filed by 6 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.

• 20231 clearance
• 20131 clearance
• 19862 clearances
• 19841 clearance
• 19821 clearance
• 19811 clearance
• 19781 clearance

• Convaid Products, Inc.3 clearances
• Mednet, Inc.1 clearance
• Ki Mobility, LLC1 clearance
• Kaye Products, Inc.1 clearance
• Columbia Medical Mfg, LLC1 clearance
• Asc Corp.1 clearance

• K223533 — Little Wave Arc; Little Wave FlipKi Mobility, LLC·2023-08-31
• K130644 — PEDIATRIC FOLDING WHEELCHAIRColumbia Medical Mfg, LLC·2013-10-16
• K863450 — SULKY SPECIALAsc Corp.·1986-10-23
• K862888 — PERAMBULATOR (STROLLER)Mednet, Inc.·1986-08-13
• K840250 — CARRIERConvaid Products, Inc.·1984-02-09
• K820591 — MECHANICAL CHAIRKaye Products, Inc.·1982-03-15
• K810676 — CONVAID CRUISER CP4MConvaid Products, Inc.·1981-03-26
• K781947 — STROLLER, THERAPYConvaid Products, Inc.·1978-12-04