2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM— 510(k) K122112
Substantially EquivalentBio Compression Systems, Inc.
FDA 510(k) clearance K122112 for 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM, Substantially Equivalent on 2013-04-09. Applicant: Bio Compression Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Compression Systems, Inc.
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toms River, NJ, US
Recent devices under product code IRP
view all- K261887 — Normatec Elite Heat (6 models)
- K262812 — Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- K260944 — ManaCold Compression System
- K260529 — Air Compression Massager (HY-1165)
- K260948 — Air Compression Massager (EP30B001 I)
More clearances from Bio Compression Systems, Inc.
view all- K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)
- K250974 — Bio Arterial Deluxe (IC-BAP-DX)
- K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K180248 — VascuEase IC-1200-WH
Data sourced from openFDA. This site is unofficial and independent of the FDA.