Headlamp, Operating, Battery-Operated
Black Double Ratchet Headband with Occipital Pad Support and attached bracket
4manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Nanjing Yanan Special Lighting Factory | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Enova Illumination, Inc, United States |
|---|---|
| FDA product code | HPP |
| Device type | Headlamp, Operating, Battery-Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-13 |
| Record revised | 2023-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Handling environment humidity 48 to 85 % RH; Handling environment temperature -20 to 40 °C; Storage environment humidity 48 to 85 % RH; Storage environment temperature -20 to 70 °C |
| Distribution end date | 2028-01-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5460-700-029 | In distribution | |
| 5460-700-020 | In distribution | |
| 5460-700-025 | In distribution | |
| 5460-700-022 | In distribution | |
| 5460-700-032 | In distribution | |
| 5460-700-021 | In distribution | |
| 5460-700-033 | In distribution | |
| 5460-700-031 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enova Illumination | Enova Illumination, Inc | 79 |
| MedLED Chrome | Riverpoint Medical LLC | 41 |
| Jedmed | Jedmed Instrument Company | 28 |
| MedLED Spectra | Riverpoint Medical LLC | 27 |
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| MedLED | Riverpoint Medical LLC | 19 |
| Quasar | Enova Illumination, Inc | 12 |
| Qosmic | Enova Illumination, Inc | 11 |
| BR Surgical, LLC | BR Surgical LLC | 10 |
| Quantum | Enova Illumination, Inc | 10 |
| MaxLite Elite | Riverpoint Medical LLC | 10 |
| MedLED Face Shield | Riverpoint Medical LLC | 8 |
Showing 12 of 68. All products under Headlamp, Operating, Battery-Operated
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.