FDA device listing
Apollo - Partial Foot Decompression Shoe with zero-heel technology,Jupiter - Forefoot Relief Shoe,Komet - Especially low…
FDA device listing 1990487627 · Streifeneder ortho.production GmbH
Key facts
| Proprietary names | Apollo - Partial Foot Decompression Shoe with zero-heel technology,Jupiter - Forefoot Relief Shoe,Komet - Especially low Partial Foot Decompression Shoe in outdoor-design,Luna - Longterm Surgical Shoe with 3 removable cushioning soles and reinforced outsole,Mars - Heel Relief Shoe,Mars S - Heel Relief Shoe,Merkur A - Partial Foot Decompression Shoe (Post-Surgical Shoe),Merkur - Forefoot Relief… |
|---|---|
| Owner/operator | Streifeneder ortho.production GmbH |
| Owner/operator number | 8010401 |
| Product codes | KNP |
| Device names | KNP - Orthosis, Corrective Shoe |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | STREIFENEDER ortho.production gmbH |
| Establishment registrations | 8010401 |
| FEI numbers | 5812 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database