The following data is part of a premarket notification filed by Sensible Medical Innovations Ltd. with the FDA for Reds Wearable System.
| Device ID | K150095 |
| 510k Number | K150095 |
| Device Name: | ReDs Wearable System |
| Classification | Plethysmograph, Impedance |
| Applicant | SENSIBLE MEDICAL INNOVATIONS LTD. 4 HAALON ST. KEFAR NETER POB 8702 Netanya, IL 4059300 |
| Contact | Inbal Ben-tzvi |
| Correspondent | Janice Hogan HOGAN LOVELLS US LLP 1835 MARKET ST Suite 2920 Philadelphia, PA 19103 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-16 |
| Decision Date | 2015-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110070212 | K150095 | 000 |
| 07290110070021 | K150095 | 000 |
| 07290110070038 | K150095 | 000 |
| 07290110070045 | K150095 | 000 |
| 07290110070090 | K150095 | 000 |
| 07290110070106 | K150095 | 000 |
| 07290110070113 | K150095 | 000 |
| 07290110070120 | K150095 | 000 |
| 07290110070205 | K150095 | 000 |
| 07290110070014 | K150095 | 000 |