The following data is part of a premarket notification filed by Harmony Hill International with the FDA for Profthand Mechanical Wheelchair.
| Device ID | K123076 |
| 510k Number | K123076 |
| Device Name: | PROFTHAND MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | HARMONY HILL INTERNATIONAL RM. 1068, 10F, H BLDG. OF NKSP, NO.3-2 PARK ST., NANGANG DIST Taipei, TW 11503 |
| Contact | Tina Lai |
| Correspondent | Tina Lai HARMONY HILL INTERNATIONAL RM. 1068, 10F, H BLDG. OF NKSP, NO.3-2 PARK ST., NANGANG DIST Taipei, TW 11503 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-08-09 |
| Summary: | summary |