FDA Device Establishments · JSON-LD · Markdown
FEI 3006622779 · Manufacture Medical Device · Status: Active
| FEI Number | 3006622779 |
|---|---|
| Owner / Operator | KARIS Co., Ltd. (#10046700) |
| Address | 23-19 Wolha-ro, 671 beon-gil, Haseong-myeon, Gimpo-si Gyeonggi, 415-887, KR |
| Mandatory US Agent | KMC USA, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IRQ |
| Regulation § (21 CFR) | 890.5950 |
| Proprietary names | Moist Hot-Pack Unit (Models: KRS-4P-D2D32, KRS-6P- D2D32, KRS-8P- D2D32, KRS-12P- D2D32, KRS-24P- D2D32); Relief Pak 24 pack heating Unit or Relief Pak 24 pack heating Unit mobile (Model: 11-1986); Moist Hot-Pack Unit (Models: KRS-4PAFA(MET), KRS-6PAFA(MET), KRS-8PAFA(MET), KRS-12PAFA(MET), KRS-24PAFA(MET)); Relief Pak 12 pack heating Unit or Relief Pak 12 pack heating Unit mobile (Model: 11-1985); Relief Pak 4 pack heating Unit stationary (Model: 11-1980); Moist Hot-Pack Unit (Models: KRS-4PUF, KRS-6PUF, KRS-8PUF, KRS-12PUF, KRS-24PUF); Moist Hot-Pack Unit (Models: KRS-4PUB, KRS-6PUB, KRS-8PUB, KRS-12PUB, KRS-24PUB); Relief Pak 4 pack heating Unit or Relief Pak 4 pack heating Unit stationary (Model: 11-1981); Moist Hot-Pack Unit (Models: KRS-4PAFD(MET), KRS-6PAFD(MET), KRS-8PAFD(MET), KRS-12PAFD(MET), KRS-24PAFD(MET)); Moist Hot-Pack Unit (Models: KRS-6P-A1A32, KRS-8P-A1A32, KRS-12P-A1A32, KRS-24P-A1A32) |
Source: openFDA. Public-domain (CC0).