The following data is part of a premarket notification filed by Aci Medical, Inc. with the FDA for Art-assist Model Aa-1000.
| Device ID | K942530 |
| 510k Number | K942530 |
| Device Name: | ART-ASSIST MODEL AA-1000 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ACI MEDICAL, INC. 1857 DIAMOND ST. San Marcos, CA 92069 |
| Contact | Ed Arkans |
| Correspondent | Ed Arkans ACI MEDICAL, INC. 1857 DIAMOND ST. San Marcos, CA 92069 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1996-02-28 |