Transport, Patient, Powered

Device Code: 5074

Product Code(s): ILK

Device Classification Information

• Device Type ID: 5074
• Device Name: Transport, Patient, Powered
• Regulation Description: Powered Patient Transport.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(k)
• CFR Regulation Number: 890.5150 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ILK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 16-199 ISO 7176-28 First Edition 2012-10-1
  Wheelchairs Part 28: Requirements And Test Methods For Stairclimbing Devices

Total Product Life Cycle

• Device Type ID: 5074
• Device: Transport, Patient, Powered
• Product Code: ILK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Powered Patient Transport.
• CFR Regulation Number: 890.5150 [🔎]

Premarket Reviews
Manufacturer	Decision
AAT ALBER ANTRIEBSTECHNIK GMBHJ
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Insufficient Information	2
Device Handling Problem	1
Improper Or Incorrect Procedure Or Method	1
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Savaria Concord Lifts, Inc.	II	Apr-27-2017
2	Savaria Concord Lifts, Inc.	II	Apr-26-2017

TPLC Last Update: 2019-04-02 20:59:47