The following data is part of a premarket notification filed by Theradapt Products, Inc. with the FDA for Theradapt Highchair/stroller Insert.
| Device ID | K942397 |
| 510k Number | K942397 |
| Device Name: | THERADAPT HIGHCHAIR/STROLLER INSERT |
| Classification | Chair, Adjustable, Mechanical |
| Applicant | THERADAPT PRODUCTS, INC. 17 W. 163 OAK LN. Bensenville, IL 60106 |
| Contact | Beverly Richardson |
| Correspondent | Beverly Richardson THERADAPT PRODUCTS, INC. 17 W. 163 OAK LN. Bensenville, IL 60106 |
| Product Code | INN |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-06-22 |