FDA Registration
Active
🇺🇸 United States
THE JAY GROUP
Reg #: 3006479639
·
FEI: 3006479639
·
Expires 2026
Products
14
Proprietary Names
13
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- THE JAY GROUP
- Registration Number
- 3006479639
- FEI Number
- 3006479639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 700 Indian Springs Drive
- City
- Lancaster
- State
- PA
- ZIP
- 17601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041545
Owner / Operator
- Firm Name
- The Jay Group
- Operator Number
- 10021837
- Address
- 700 Indian Springs Drive
- City
- Lancaster
- State
- PA
- Postal Code
- 17601
- Country
- US
- Correspondent
- Gene Palow
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-10-02 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2025-06-19 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2026-06-08 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2007-10-02 |
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2026-06-08 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-06-08 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2026-04-23 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2026-04-23 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2026-04-23 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2026-06-08 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2022-08-11 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-08-11 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2023-10-30 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2025-06-19 |
Proprietary Names
BD
TPC Inc. DBA August
Lelo Usa Inc.
Animas
Healthyio
Lelo Hex Lubricated Natural Rubber Latex Condom; Lelo Hex Lubricated Natural Rubber Latex Condom 12s; Lelo Hex Lubricat
MOSIE LLC
Fillow
Lily Cup One; Ziggy Cup
Sequel
HEX Condoms Respect 12 Pack; HEX Condoms Respect 3 Pack; HEX Condoms Respect 36 Pack; LELO RESPECT HEX Natural Rubber La
HEX Condoms Original 12 Pack (US_TNR); HEX Condoms Original 3 Pack (US_TNR); HEX Condoms Original 36 Pack (US_TNR); HEX
Banana Gold
Establishment Types
Repack or Relabel Medical Device