The following data is part of a premarket notification filed by Spinergy, Inc. with the FDA for Zx-i Power Add On.
| Device ID | K123769 |
| 510k Number | K123769 |
| Device Name: | ZX-I POWER ADD ON |
| Classification | Wheelchair, Powered |
| Applicant | SPINERGY, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll SPINERGY, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-05-10 |
| Summary: | summary |