TAPE & BANDAGE, ADHESIVE
Device Facts
| Record ID | K955270 |
|---|---|
| Device Name | TAPE & BANDAGE, ADHESIVE |
| Applicant | Robert R. Stevens |
| Product Code | DXC · Cardiovascular |
| Decision Date | Aug 8, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4450 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Cutaneous Compression Device for General Hospital Use.
Device Story
Cutaneous compression device; used in general hospital settings; provides compression to skin surface; intended for general hospital use; operated by healthcare personnel; aids in management of cutaneous compression needs.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Class I adhesive tape and bandage device; mechanical compression function; no specific materials or standards cited.
Indications for Use
Indicated for general hospital use as a cutaneous compression device.
Regulatory Classification
Identification
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
Predicate Devices
- Cutaneous Compression Device for Hemodialysis (K951973)
Related Devices
- K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES · Primeline Medical Products, Inc. · Jun 22, 1997
- K983016 — GAUZE, SPONGES, CAT # 11-003 · Vitalcare Group, Inc. · Feb 12, 1999
- K203019 — LF900 · Daesung Maref Co., Ltd. · Jun 22, 2021
- K202839 — Overlapped Compression Therapy · Jkh Health Co., Ltd. · Jan 21, 2021
- K961797 — WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE · Wright Linear Pump, Inc. · Nov 6, 1996
Submission Summary (Full Text)
{0}
K955270
AUG 8 1996
# X. Summary of Safety and Effectiveness
**Classification Name:** Tape and Bandage, Adhesive
21 C.F.R. § 880.5240 (1994).
**Common/Usual Name:** Cutaneous Compression Device for General Hospital Use.
**Proprietary Name:** At present, no proprietary name has been chosen for this device.
**Establishment Registration:** Mr. Robert R. Stevens has not yet engaged in activities requiring establishment registration. Upon engaging in such activities, an establishment registration will be filed in accordance with the requirements set forth at 21 C.F.R. § 807.20 (1994).
**Classification:** Under Section 513 of the Federal Food, Drug, and Cosmetic Act, this device is classified into Class I.
**Performance Standards:** As of the date of this Premarket Notification submission, no Performance Standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act. As such, no actions have been taken to comply with Section 514 Performance Standards.
**Labeling/Promotional Materials:** Proposed labeling is included in this submission.
**Substantial Equivalence:** This device is substantially equivalent to the following legally-marketed device ("Predicate Device") in terms of safety, effectiveness, and intended use:
**Product:** Cutaneous Compression Device for Hemodialysis
**Manufacturer:** Mr. Robert R. Stevens
510(k) Number: K951973
Substantial Equivalence Date: Class I exempt.
- 14 -
