FDA Device Registration & Listing · SHANGHAI, CN · Registration 3005951403
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| IOY | Support, Arm | Physical Medicine | Class 1 | 890.3475 | 2022-10-18 |
| NXQ | Reminder, Medication | Physical Medicine | Class 1 | 890.5050 | 2022-10-18 |
| LZB | Finger Cot | General Hospital | Class 1 | 880.6250 | 2020-10-11 |
| FPF | Bottle, Hot/Cold Water | General Hospital | Class 1 | 880.6085 | 2010-12-25 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2010-12-25 |
| IPT | Orthosis, Thoracic | Physical Medicine | Class 1 | 890.3490 | 2021-10-18 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2007-12-10 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2020-10-11 |
| FSD | Binder, Abdominal | General Hospital | Class 1 | 880.5160 | 2022-10-18 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2007-12-10 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2007-12-10 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2006-08-03 |
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | Class 1 | 880.5780 | 2010-12-25 |
| NXB | Dispenser, Solid Medication | Physical Medicine | Class 1 | 890.5050 | 2010-12-25 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-04-05 |
| EGD | Wax, Dental, Intraoral | Dental | Class 1 | 872.6890 | 2024-11-20 |
| IQK | Orthosis, Cervical | Physical Medicine | Class 1 | 890.3490 | 2021-10-18 |
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | Class 1 | 890.3490 | 2021-10-15 |
| KYS | Insoles, Medical | General Hospital | Class 1 | 880.6280 | 2010-12-25 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2024-11-20 |
| ILG | Stocking, Elastic | Physical Medicine | Class 1 | 890.3475 | 2022-10-18 |
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | Class 1 | 890.3025 | 2022-10-18 |
| KYR | Bag, Ice | General Hospital | Class 1 | 880.6050 | 2007-12-10 |
| IPW | Orthosis, Sacroiliac, Soft | Physical Medicine | Class 1 | 890.3490 | 2018-11-26 |
| IPX | Orthosis, Rib Fracture, Soft | Physical Medicine | Class 1 | 890.3490 | 2021-10-18 |
| ISH | Component, External, Limb, Ankle/Foot | Physical Medicine | Class 1 | 890.3420 | 2010-12-25 |
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | Class 1 | 862.1485 | 2023-06-08 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2024-11-20 |
| ITQ | Joint, Knee, External Brace | Physical Medicine | Class 1 | 890.3475 | 2010-12-25 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2010-12-25 |
| FQJ | Support, Scrotal, Therapeutic | General Hospital | Class 1 | 880.5820 | 2020-10-11 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2010-12-25 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2024-11-20 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2007-12-10 |
| IQE | Orthosis, Lumbar | Physical Medicine | Class 1 | 890.3490 | 2021-10-18 |
| NJB | Orthosis, Truncal, For Dysmenorrhea | Physical Medicine | Class 1 | 890.3490 | 2021-10-18 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2009-12-04 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2024-11-20 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2020-10-11 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2021-07-14 |
| OMW | Adhesive Backed Thermal Skin Patches | Physical Medicine | Class 1 | 890.5710 | 2020-10-11 |
| MMD | Toothbrush, Ionic, Battery-Powered | Dental | Class 1 | 872.6865 | 2024-11-20 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2010-12-25 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2010-12-25 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2006-08-03 |
| ILE | Sling, Arm, Overhead Supported | Physical Medicine | Class 1 | 890.3475 | 2021-10-18 |
| LYG | Massager, Therapeutic, Manual | Physical Medicine | Class 1 | 890.5660 | 2021-07-14 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | Physical Medicine | Class 1 | 890.3490 | 2018-11-26 |
| FZF | Splint, Extremity, Inflatable, External | General, Plastic Surgery | Class 1 | 878.3900 | 2010-12-25 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K880871 | John Wagner Associates, Inc. | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | 1988-05-20 |
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| K915446 | Sun Glitz Corp. | STRETCH WRAP | 1992-05-06 |
| K833120 | Acme United Corp. | ONE TIME COMPOUND BENZOIN TINCTURE- | 1983-12-29 |
| K870091 | Avery Intl. | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | 1987-02-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0505-2022 | Philips North America Llc | 1 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 |
| Z-0506-2022 | Philips North America Llc | 1 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 |
| Z-0006-2025 | Ossur H F Grjothals 5 Reykjavik Iceland | 1 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3043730244 | DALIAN WACOAL CO., LTD. | Dalian Economic and Technological Development Zone Liaoning, CN |
| 3010508273 | LIANG CHENG SPORTING GOODS COMPANY LIMITED | Ben Cat Town Binh Duong, VN |
| 1649518 | Sterigenics US LLC | Fort Worth, TX, US |
| 3007207474 | BARBARAS DEVELOPMENT, INC. | Thousand Oaks, CA, US |
| 3017619379 | Jiangsu Juneng Sports Goods Technology Co., Ltd | Yangzhou Jiangsu, CN |
3005951403 when referencing this establishment in official correspondence.