Warm & Form, Orthopedic Materials
Mchenry, IL, US
Warm & Form, Orthopedic Materials appears in FDA device records in Mchenry, IL. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Warm & Form, Orthopedic Materials between 1982 and 1983. The busiest year on record is 1982, with 20. The most recent is 1983, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 20 |
| 1983 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K830245 | HEAD HALTER | ILZ | Substantially Equivalent | |
| K830244 | TRACTION ACCESSORIES | HST | Substantially Equivalent | |
| K830243 | ABDUCTION PILLOW | IOZ | Substantially Equivalent | |
| K830246 | CAST SHOE, CAST BOOT | JQB | Substantially Equivalent | |
| K823667 | CERVICAL COLLAR | IQK | Substantially Equivalent | |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | ILH | Substantially Equivalent | |
| K823665 | ROTATION BOOT | KNP | Substantially Equivalent | |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | ILI | Substantially Equivalent | |
| K823663 | ABDOMINAL BINDER | KTD | Substantially Equivalent | |
| K823662 | RIB BELT (UNIVERSAL) | IPX | Substantially Equivalent | |
| K823661 | CLAVICLE SUPPORT | IQJ | Substantially Equivalent | |
| K823660 | UNIVERSAL BUCKS TRACTION | KQZ | Substantially Equivalent | |
| K823659 | PELVIC TRACTION BELT | ILZ | Substantially Equivalent | |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | ITQ | Substantially Equivalent | |
| K823165 | WRIST SPLING & FOREARM SPLINT | ILH | Substantially Equivalent | |
| K823164 | ABDOMINAL BINDER | KTD | Substantially Equivalent | |
| K823166 | PELVIC TRACTION BELT | ILZ | Substantially Equivalent | |
| K823163 | UNIVERSAL BUCKS TRACTION | KQZ | Substantially Equivalent | |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | ILI | Substantially Equivalent | |
| K823161 | CERVICAL COLLAR | IQK | Substantially Equivalent | |
| K823160 | ROTATION BOOT | IQI | Substantially Equivalent | |
| K823159 | DELUXE KNEE IMMOBILIZER | ITQ | Substantially Equivalent | |
| K823158 | RIB BELT (UNIVERSAL) | IPX | Substantially Equivalent | |
| K823157 | CLAVICLE SUPPORT | IQJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- ILZAccessories, Traction
- HSTApparatus, Traction, Non-Powered
- KQZComponent, Traction, Non-Invasive
- ITQJoint, Knee, External Brace
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- KTDOrthosis, Abdominal
- IQKOrthosis, Cervical
- KNPOrthosis, Corrective Shoe
- IQIOrthosis, Limb Brace
- IPXOrthosis, Rib Fracture, Soft
- ILISling, Arm
- IOZSplint, Abduction, Congenital Hip Dislocation
- IQJSplint, Clavicle
- ILHSplint, Hand, And Components
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
