The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Olympus Mobile Chair/couch.
| Device ID | K962528 |
| 510k Number | K962528 |
| Device Name: | OLYMPUS MOBILE CHAIR/COUCH |
| Classification | Chair, Surgical, Non-electrical |
| Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
| Product Code | FZK |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1996-12-12 |