FDA Device Registration & Listing · Appleton, WI, US · Registration 3006789548
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2014-06-03 |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | Class 1 | 878.3910 | 2014-06-03 |
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | Class 1 | 890.3490 | 2014-06-03 |
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | Class 1 | 878.4730 | 2014-06-03 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2014-06-03 |
| EPP | Splint, Nasal | Ear, Nose, Throat | Class 1 | 874.5800 | 2014-06-03 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2014-06-03 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2014-06-03 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2014-06-03 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2014-06-03 |
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | Class 1 | 880.5780 | 2014-06-03 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2014-06-03 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2014-06-03 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2014-06-03 |
| IOY | Support, Arm | Physical Medicine | Class 1 | 890.3475 | 2014-06-03 |
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | Class 1 | 890.3025 | 2014-06-03 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2014-06-03 |
| FQJ | Support, Scrotal, Therapeutic | General Hospital | Class 1 | 880.5820 | 2014-06-03 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2014-06-03 |
| ITQ | Joint, Knee, External Brace | Physical Medicine | Class 1 | 890.3475 | 2014-06-03 |
| FZF | Splint, Extremity, Inflatable, External | General, Plastic Surgery | Class 1 | 878.3900 | 2014-06-03 |
| KYR | Bag, Ice | General Hospital | Class 1 | 880.6050 | 2014-06-03 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010952189 | Vernon Area Rehabilitation Center, Inc. - Juneau Division | Mauston, WI, US |
| 3010872396 | Vernon Area Rehabilitation Center, Inc. - Viroqua Division | Viroqua, WI, US |
| 3010951384 | Vernon Area Rehabilitation Center, Inc. - Richland Division | Richland Center, WI, US |
| 3015337116 | Vernon Area Rehabilitation Center, Inc. - La Crosse Division | La Crosse, WI, US |
| 3010951382 | Vernon Area Rehabilitation Center, Inc. - Sauk Division | Reedsburg, WI, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K880871 | John Wagner Associates, Inc. | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | 1988-05-20 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004472848 | VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED | ZHANGJIAGANG Jiangsu, CN |
| 3014125510 | JIANGMEN HENG MEI GLOVES & DECORATION CO. LTD. | JIANGMEN Guangdong, CN |
| 3023344913 | AR ORTHOPEDICS, LLC | Newberry, FL, US |
| 3041725026 | Fill Mill | Lakewood, NJ, US |
| 3012316249 | COMPASS HEALTH BRANDS (CORPORATE OFFICE) | Middleburg Heights, OH, US |
3006789548 when referencing this establishment in official correspondence.