Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 With LiNX Electronics, TDXSP2-CG TDX SP2 Base For Single Act. System W/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base For Multiple Actuator System W/ Ultra Low Maxx

Wheelchair, Powered

Invacare Corporation

The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare® Tdx® Sp2 Power Wheelchair; Tdxsp2 Tdx Sp2 With Linx Electronics, Tdxsp2-cg Tdx Sp2 Base For Single Act. System W/ Ultra Low Maxx, Tdxsp2-mcg Tdx Sp2 Base For Multiple Actuator System W/ Ultra Low Maxx.

Pre-market Notification Details

• Device ID: K170507
• 510k Number: K170507
• Device Name: Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 With LiNX Electronics, TDXSP2-CG TDX SP2 Base For Single Act. System W/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base For Multiple Actuator System W/ Ultra Low Maxx
• Classification: Wheelchair, Powered
• Applicant: Invacare Corporation One Invacare Way Elyria, OH 44035
• Contact: Elijah N. Wreh
• Correspondent: Elijah N. Wreh; Invacare Corporation One Invacare Way Elyria, OH 44035
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-21
• Decision Date: 2017-07-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841447101512	K170507	000
00841447101017	K170507	000
00841447101000	K170507	000
00841447100966	K170507	000
00841447100942	K170507	000
00841447100911	K170507	000