The following data is part of a premarket notification filed by P.d.g., Inc. with the FDA for Model Luna Manual Wheelchair.
| Device ID | K102910 |
| 510k Number | K102910 |
| Device Name: | MODEL LUNA MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | P.D.G., INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll P.D.G., INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B829971 | K102910 | 000 |