Product code HRW— Orthopedic

FDA has cleared 12 devices under product code HRW between 1977 and 1998, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19981 clearance
• 19971 clearance
• 19891 clearance
• 19861 clearance
• 19821 clearance
• 19811 clearance
• 19801 clearance
• 19792 clearances
• 19782 clearances
• 19771 clearance

• Fred Sammons, Inc.6 clearances
• Zatek1 clearance
• The Orthodyn Co.1 clearance
• Spark Instruments & Academics, Inc.1 clearance
• Optik1 clearance
• Nk Biotechnical Corp.1 clearance
• J-Tech Medical, Inc.1 clearance

• K971407 — JTECH COMMANDER AND ALGOMETERJ-Tech Medical, Inc.·1998-04-20
• K970870 — DIGIT-GRIP WITH LCD (DGR002)Nk Biotechnical Corp.·1997-05-02
• K894557 — LIGHTSCOPE SETOptik·1989-08-07
• K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111Spark Instruments & Academics, Inc.·1986-05-02
• K821631 — PINCH GAUGE, 0-301 LBS.Fred Sammons, Inc.·1982-06-11
• K812343 — PINCH METERFred Sammons, Inc.·1981-09-11
• K801719 — BK-7531 PAIN THRESHOLD/FINGER FORCE GAUGFred Sammons, Inc.·1980-08-04
• K791021 — MUSCLE TESTING GUNThe Orthodyn Co.·1979-06-15
• K790302 — PRESSURE MONITOR, MODEL 212Zatek·1979-03-21
• K772413 — PINCH GUAGEFred Sammons, Inc.·1978-01-05
• K772415 — DYNAMETER 50 LB.Fred Sammons, Inc.·1978-01-05
• K771288 — JAMAR DYNAMOMETEO BK-7498Fred Sammons, Inc.·1977-07-21