The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Model R Series Positioning System For Powered Wheelchair.
| Device ID | K113577 |
| 510k Number | K113577 |
| Device Name: | MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Contact | Steve Chao |
| Correspondent | Steve Chao MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379292398 | K113577 | 000 |
| 04714379291698 | K113577 | 000 |
| 04714379290943 | K113577 | 000 |
| 04714379291919 | K113577 | 000 |
| 04714379292497 | K113577 | 000 |
| 04714379292701 | K113577 | 000 |
| 04714379293586 | K113577 | 000 |
| 04714379294545 | K113577 | 000 |
| 04714379295641 | K113577 | 000 |
| 04714379296914 | K113577 | 000 |
| 04714379296907 | K113577 | 000 |
| 04714379298529 | K113577 | 000 |
| 04714379291872 | K113577 | 000 |
| 04714379291971 | K113577 | 000 |
| 04714379292022 | K113577 | 000 |
| 04714379292367 | K113577 | 000 |
| 04714379292350 | K113577 | 000 |
| 04714379292343 | K113577 | 000 |
| 04714379292336 | K113577 | 000 |
| 04714379292305 | K113577 | 000 |
| 04714379292145 | K113577 | 000 |
| 04714379292138 | K113577 | 000 |
| 04714379292121 | K113577 | 000 |
| 04714379292060 | K113577 | 000 |
| 04714379292046 | K113577 | 000 |
| 04714379292039 | K113577 | 000 |
| 04714379298512 | K113577 | 000 |