FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPRESSION DEVICES, LIMB
K Number: K781964
·
Decision Dec 12, 1978
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
8
Review Days
22
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Basic Information
- Device Name
- COMPRESSION DEVICES, LIMB
- K Number
- K781964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Alba-Waldensian, Inc.
- Date Received
- November 20, 1978
- Decision Date
- December 12, 1978
- Product Code
- IRP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Alba-Waldensian, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020592 | ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 | Apr 3, 2002 | Substantially Equivalent |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | Dec 26, 1996 | Substantially Equivalent |
| K852091 | ALBA DRY BURN PAD | Jun 13, 1985 | Substantially Equivalent |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | Dec 18, 1979 | Substantially Equivalent |
| K780570 | TUBULAR DRESSING RETAINER | Apr 19, 1978 | Substantially Equivalent |
| K780547 | STERILE ORTHOPEDIC STOCKINETTE | Apr 10, 1978 | Substantially Equivalent |
| K771913 | HEEL/ELBOW PROTECTOR | Nov 15, 1977 | Substantially Equivalent |