# Amarigo Inc (manufacturer, Los Angeles, CA): 7 new FDA device listings, incl. stimulator, electrical, non-implantable, for incontinence

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Amarigo Inc |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Los Angeles, CA, US |
| New listings | 7 |
| Devices | Stimulator, Electrical, Non-Implantable, For Incontinence; Sunglasses (Non-Prescription Including Photosensitive); Spatula, Surgical, General & Plastic Surgery; Pad, Heating, Powered; Catheters, Suction, Tracheobronchial; Brush, Dermabrasion, Powered; Massager, Therapeutic, Electric |
| Product codes | KPI, HQY, GAF, IRT, BSY, GFE, ISA |
| Device classes | Class I, Class II |
| Medical specialties | Gastroenterology, Urology, Ophthalmic, General, Plastic Surgery, Physical Medicine, Anesthesiology |
| Brand names | Pelvic Floor Stimulator (Intrelief PFE); SUNGLASSES:A8pro,T8pro,A8,A9,588,628,818,788,S6,AI99,AI68, A31,A31plus,M31,628S,A8 Ultra; Blackhead Remover:SL0001-1; Blackhead spatula:GUGU-FS-XK-VO3, BS-357; Rechargeable heating pad:102409; Nasal Aspirator:ASP-402, ASP-401; Facial device:W-1001-W; Facial cleansing device:GUGU-FS-XK-VO3, BS-357 |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-09-24 |
| FDA registration number | 3027135885 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.