The following data is part of a premarket notification filed by Osachi Co., Ltd. with the FDA for Pain Vision, Model Ps-2100.
| Device ID | K072882 |
| 510k Number | K072882 |
| Device Name: | PAIN VISION, MODEL PS-2100 |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | OSACHI CO., LTD. 3027 E. SUNSET RD., SUITE 105 Las Vegas, NV 89120 |
| Contact | James R Greenwood |
| Correspondent | James R Greenwood OSACHI CO., LTD. 3027 E. SUNSET RD., SUITE 105 Las Vegas, NV 89120 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-09 |
| Decision Date | 2009-01-08 |
| Summary: | summary |