FDA Registration
Active
🇺🇸 United States
BIOINTELLISENSE INC.
Reg #: 3017986070
·
FEI: 3017986070
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOINTELLISENSE INC.
- Registration Number
- 3017986070
- FEI Number
- 3017986070
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 17301 W. Colfax Ave., Suite 152
- City
- Golden
- State
- CO
- ZIP
- 80401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212957
Owner / Operator
- Firm Name
- BioIntelliSense Inc.
- Operator Number
- 10062701
- Address
- 805 Veterans Blvd, UNIT 105
- City
- Redwood City
- State
- CA
- Postal Code
- 94063
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-12-14 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2022-12-14 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2024-09-30 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-02-09 |
Proprietary Names
BioButton
BioButton wearable device
BioButton remote patient monitoring device
BioButton wearable sensor
BioSticker
BioSticker wearable sensor
BioSticker on-body sensor
BioSticker wearable device
BioSticker remote patient monitoring device
BioButton Charging Station
BioButton System (Multi-patient Use or MPU)
BioButton MPU
BioButton v3
BioButton Rechargeable (BBR)
BioButton Rechargeable
BioButton Adhesives v2 (2x5pcs and 50x5pcs, HT, ADD, ADH-AC1-BBR)
BioButton Adhesives v1 (2x5pcs and 50x5pcs, OMI, ADB, ACCS-1-ST06-1-4F)
BioButton Adhesive V2, Cold Seal (ADH-CS)
Establishment Types
Repack or Relabel Medical Device