The following data is part of a premarket notification filed by Parker-hannifin Corporation with the FDA for Indego(r).
| Device ID | K173530 |
| 510k Number | K173530 |
| Device Name: | Indego(R) |
| Classification | Powered Exoskeleton |
| Applicant | Parker-Hannifin Corporation 1390 E. Highland Road Macedonia, OH 44056 |
| Contact | Achilleas Dorotheou |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg 1, Suite 300 Austin, TX 78746 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-15 |
| Decision Date | 2018-01-31 |
| Summary: | summary |